Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-01-01 @ 8:58 PM
Study NCT ID:
NCT00857857
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2009-03-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581038', 'term': 'GW870086X'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 17 weeks)', 'description': 'All subject population used.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Prostatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.903', 'groupId': 'OG000', 'lowerLimit': '-1.126', 'upperLimit': '-0.679'}, {'value': '-0.663', 'groupId': 'OG001', 'lowerLimit': '-0.918', 'upperLimit': '-0.407'}, {'value': '-0.638', 'groupId': 'OG002', 'lowerLimit': '-0.896', 'upperLimit': '-0.380'}, {'value': '-0.446', 'groupId': 'OG003', 'lowerLimit': '-0.698', 'upperLimit': '-0.194'}, {'value': '-0.376', 'groupId': 'OG004', 'lowerLimit': '-0.630', 'upperLimit': '-0.123'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.240', 'ciLowerLimit': '0.031', 'ciUpperLimit': '0.449', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1033', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.265', 'ciLowerLimit': '0.053', 'ciUpperLimit': '0.477', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1048', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.456', 'ciLowerLimit': '0.255', 'ciUpperLimit': '0.657', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0993', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.526', 'ciLowerLimit': '0.319', 'ciUpperLimit': '0.733', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1025', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4-10 hours after allergen challenge on Day 13 of each treatment period', 'description': 'Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The all subject population was used which was defined as all participants who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.550', 'groupId': 'OG000', 'lowerLimit': '-0.744', 'upperLimit': '-0.356'}, {'value': '-0.340', 'groupId': 'OG001', 'lowerLimit': '-0.567', 'upperLimit': '-0.113'}, {'value': '-0.396', 'groupId': 'OG002', 'lowerLimit': '-0.626', 'upperLimit': '-0.167'}, {'value': '-0.248', 'groupId': 'OG003', 'lowerLimit': '-0.471', 'upperLimit': '-0.024'}, {'value': '-0.146', 'groupId': 'OG004', 'lowerLimit': '-0.371', 'upperLimit': '0.078'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.210', 'ciLowerLimit': '0.013', 'ciUpperLimit': '0.407', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0975', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.154', 'ciLowerLimit': '-0.046', 'ciUpperLimit': '0.354', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0988', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.303', 'ciLowerLimit': '0.113', 'ciUpperLimit': '0.492', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0937', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.404', 'ciLowerLimit': '0.209', 'ciUpperLimit': '0.599', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0966', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '4-10 hours after allergen challenge on Day 13 of each treatment period', 'description': 'Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Weighted mean LAR was calculated for FEV1 over 4-10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours) post allergen challenge using the linear trapezoidal rule. To calculate weighted mean LAR, all FEV1 values recorded after the administration of rescue medication have been set to the last recorded FEV1 value prior to the administration of rescue medication. The adjusted mean is presented as Least square mean (LSM).', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Minimum FEV1', 'categories': [{'measurements': [{'value': '-1.339', 'groupId': 'OG000', 'lowerLimit': '-1.603', 'upperLimit': '-1.075'}, {'value': '-1.364', 'groupId': 'OG001', 'lowerLimit': '-1.675', 'upperLimit': '-1.052'}, {'value': '-1.233', 'groupId': 'OG002', 'lowerLimit': '-1.549', 'upperLimit': '-0.918'}, {'value': '-1.100', 'groupId': 'OG003', 'lowerLimit': '-1.407', 'upperLimit': '-0.794'}, {'value': '-0.805', 'groupId': 'OG004', 'lowerLimit': '-1.113', 'upperLimit': '-0.496'}]}]}, {'title': 'Weighted Mean FEV1', 'categories': [{'measurements': [{'value': '-0.814', 'groupId': 'OG000', 'lowerLimit': '-1.039', 'upperLimit': '-0.589'}, {'value': '-0.760', 'groupId': 'OG001', 'lowerLimit': '-1.014', 'upperLimit': '-0.506'}, {'value': '-0.789', 'groupId': 'OG002', 'lowerLimit': '-1.045', 'upperLimit': '-0.532'}, {'value': '-0.634', 'groupId': 'OG003', 'lowerLimit': '-0.885', 'upperLimit': '-0.383'}, {'value': '-0.464', 'groupId': 'OG004', 'lowerLimit': '-0.716', 'upperLimit': '-0.212'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.025', 'ciLowerLimit': '-0.302', 'ciUpperLimit': '0.253', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1372', 'estimateComment': 'Comparison of Minimum FEV1 between Placebo and GW870086 0.25 mg.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.106', 'ciLowerLimit': '-0.176', 'ciUpperLimit': '0.387', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1391', 'estimateComment': 'Comparison of Minimum FEV1 between Placebo and GW870086 1 mg.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.239', 'ciLowerLimit': '-0.028', 'ciUpperLimit': '0.506', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1319', 'estimateComment': 'Comparison of Minimum FEV1 between Placebo and GW870086 3 mg.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.534', 'ciLowerLimit': '0.260', 'ciUpperLimit': '0.809', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1359', 'estimateComment': 'Comparison of Minimum FEV1 between Placebo and fluticasone propionate 0.25 mg BID.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.054', 'ciLowerLimit': '-0.145', 'ciUpperLimit': '0.253', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0984', 'estimateComment': 'Comparison of Weighted Mean FEV1 between Placebo and GW870086 0.25 mg.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.026', 'ciLowerLimit': '-0.176', 'ciUpperLimit': '0.228', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0998', 'estimateComment': 'Comparison of Weighted Mean FEV1 between Placebo and GW870086 1 mg.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.180', 'ciLowerLimit': '-0.011', 'ciUpperLimit': '0.371', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0945', 'estimateComment': 'Comparison of Weighted Mean FEV1 between Placebo and GW870086 3 mg.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.350', 'ciLowerLimit': '0.153', 'ciUpperLimit': '0.548', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0978', 'estimateComment': 'Comparison of Weighted Mean FEV1 between Placebo and fluticasone propionate 0.25 mg BID.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks)', 'description': 'Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 0-2 hrs post-allergen challenge (minimum EAR) was the minimum value of all the post-(bolus) allergen challenge. Weighted mean EAR was calculated for FEV1 over 0-2 hours post allergen challenge using the linear trapezoidal rule. It was measured up to and including 2 hours (5, 10, 15, 20, 30, 45 minutes and 1, 1.5 and 2 hours). The adjusted mean is presented as LSM.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.91', 'groupId': 'OG000', 'lowerLimit': '46.10', 'upperLimit': '60.72'}, {'value': '37.76', 'groupId': 'OG001', 'lowerLimit': '30.98', 'upperLimit': '46.02'}, {'value': '34.95', 'groupId': 'OG002', 'lowerLimit': '28.97', 'upperLimit': '42.16'}, {'value': '31.18', 'groupId': 'OG003', 'lowerLimit': '25.62', 'upperLimit': '37.95'}, {'value': '23.57', 'groupId': 'OG004', 'lowerLimit': '19.54', 'upperLimit': '28.43'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.56', 'ciUpperLimit': '0.90', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.116', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.82', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.107', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.47', 'ciUpperLimit': '0.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.112', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Ratio of adjusted geometric mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.55', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.107', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 13 of each treatment period (approximately 17 weeks)', 'description': 'Exhaled NO concentration data collected on Day 13 (pre-dose) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The adjusted mean is presented.', 'unitOfMeasure': 'Parts Per Billion', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'timeFrame': 'Day 13 of each treatment period (approximately 17 weeks)', 'description': 'Exhaled NO concentration data collected on Day 13 (2 and 12 hours post-dose) and was measured 3 times at each time point. The outcome was not assessed and data not reported.', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. The results were not collected for exhaled NO post-dose on Day 13.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 17 weeks', 'description': 'An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population.'}, {'type': 'SECONDARY', 'title': 'Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'DBP-Day 1, Pre dose, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '76.1', 'spread': '8.63', 'groupId': 'OG000'}, {'value': '75.8', 'spread': '9.26', 'groupId': 'OG001'}, {'value': '74.7', 'spread': '6.75', 'groupId': 'OG002'}, {'value': '76.6', 'spread': '6.58', 'groupId': 'OG003'}, {'value': '73.7', 'spread': '6.27', 'groupId': 'OG004'}]}]}, {'title': 'DBP-Day 1, 1h Post dose, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '73.8', 'spread': '7.42', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '8.81', 'groupId': 'OG001'}, {'value': '72.1', 'spread': '5.84', 'groupId': 'OG002'}, {'value': '74.5', 'spread': '4.81', 'groupId': 'OG003'}, {'value': '73.5', 'spread': '7.50', 'groupId': 'OG004'}]}]}, {'title': 'DBP-Day 7, Post dose, n=23,11,12,12,12', 'categories': [{'measurements': [{'value': '74.0', 'spread': '7.91', 'groupId': 'OG000'}, {'value': '75.3', 'spread': '10.30', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '5.71', 'groupId': 'OG002'}, {'value': '74.8', 'spread': '6.48', 'groupId': 'OG003'}, {'value': '73.8', 'spread': '7.31', 'groupId': 'OG004'}]}]}, {'title': 'DBP-Day 13, Pre saline, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '76.4', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '73.0', 'spread': '6.97', 'groupId': 'OG001'}, {'value': '75.0', 'spread': '7.47', 'groupId': 'OG002'}, {'value': '74.2', 'spread': '7.36', 'groupId': 'OG003'}, {'value': '73.5', 'spread': '7.74', 'groupId': 'OG004'}]}]}, {'title': 'DBP-Day 14, Pre challenge, n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '75.6', 'spread': '8.04', 'groupId': 'OG000'}, {'value': '74.3', 'spread': '9.08', 'groupId': 'OG001'}, {'value': '77.0', 'spread': '5.01', 'groupId': 'OG002'}, {'value': '76.0', 'spread': '8.80', 'groupId': 'OG003'}, {'value': '74.8', 'spread': '6.36', 'groupId': 'OG004'}]}]}, {'title': 'DBP-Day 14, 1h Post challenge, n=21,11,11,12,12', 'categories': [{'measurements': [{'value': '74.3', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '6.86', 'groupId': 'OG001'}, {'value': '73.5', 'spread': '6.53', 'groupId': 'OG002'}, {'value': '71.3', 'spread': '7.32', 'groupId': 'OG003'}, {'value': '72.9', 'spread': '7.33', 'groupId': 'OG004'}]}]}, {'title': 'SBP-Day 1, Pre dose, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '120.8', 'spread': '12.11', 'groupId': 'OG000'}, {'value': '119.8', 'spread': '8.55', 'groupId': 'OG001'}, {'value': '121.3', 'spread': '6.53', 'groupId': 'OG002'}, {'value': '115.8', 'spread': '8.67', 'groupId': 'OG003'}, {'value': '117.1', 'spread': '7.54', 'groupId': 'OG004'}]}]}, {'title': 'SBP-Day 1, 1h Post dose, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '123.8', 'spread': '10.34', 'groupId': 'OG000'}, {'value': '122.8', 'spread': '8.14', 'groupId': 'OG001'}, {'value': '121.5', 'spread': '6.75', 'groupId': 'OG002'}, {'value': '118.6', 'spread': '9.26', 'groupId': 'OG003'}, {'value': '119.3', 'spread': '10.75', 'groupId': 'OG004'}]}]}, {'title': 'SBP-Day 7, Post dose, n=23,11,12,12,12', 'categories': [{'measurements': [{'value': '118.3', 'spread': '11.53', 'groupId': 'OG000'}, {'value': '119.3', 'spread': '7.62', 'groupId': 'OG001'}, {'value': '119.4', 'spread': '7.81', 'groupId': 'OG002'}, {'value': '113.2', 'spread': '8.77', 'groupId': 'OG003'}, {'value': '118.7', 'spread': '5.02', 'groupId': 'OG004'}]}]}, {'title': 'SBP-Day 13, Pre saline, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '121.9', 'spread': '9.21', 'groupId': 'OG000'}, {'value': '117.6', 'spread': '7.12', 'groupId': 'OG001'}, {'value': '118.8', 'spread': '9.26', 'groupId': 'OG002'}, {'value': '120.0', 'spread': '11.80', 'groupId': 'OG003'}, {'value': '119.2', 'spread': '11.92', 'groupId': 'OG004'}]}]}, {'title': 'SBP-Day 14, Pre challenge, n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '119.7', 'spread': '11.94', 'groupId': 'OG000'}, {'value': '119.1', 'spread': '8.43', 'groupId': 'OG001'}, {'value': '124.5', 'spread': '10.08', 'groupId': 'OG002'}, {'value': '116.8', 'spread': '9.69', 'groupId': 'OG003'}, {'value': '119.0', 'spread': '8.61', 'groupId': 'OG004'}]}]}, {'title': 'SBP-Day 14, 1h Post challenge, n=21,11,11,12,12', 'categories': [{'measurements': [{'value': '123.8', 'spread': '9.50', 'groupId': 'OG000'}, {'value': '121.9', 'spread': '7.23', 'groupId': 'OG001'}, {'value': '123.7', 'spread': '7.81', 'groupId': 'OG002'}, {'value': '117.1', 'spread': '8.80', 'groupId': 'OG003'}, {'value': '119.6', 'spread': '14.22', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Participants were required to rest in the supine position for at least 10 minutes before each reading. SBP and DBP was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge \\[pre saline\\]) and Day 14 (pre and 1 hour post methacholine challenge).', 'unitOfMeasure': 'Millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).'}, {'type': 'SECONDARY', 'title': 'Mean Values for Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'HR-Day 1, Pre dose, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '64.5', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '8.50', 'groupId': 'OG001'}, {'value': '62.8', 'spread': '8.68', 'groupId': 'OG002'}, {'value': '60.5', 'spread': '6.63', 'groupId': 'OG003'}, {'value': '58.3', 'spread': '6.37', 'groupId': 'OG004'}]}]}, {'title': 'HR-Day 1, 1h Post dose, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '66.3', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '68.2', 'spread': '9.76', 'groupId': 'OG001'}, {'value': '62.7', 'spread': '9.33', 'groupId': 'OG002'}, {'value': '60.1', 'spread': '6.71', 'groupId': 'OG003'}, {'value': '62.1', 'spread': '6.69', 'groupId': 'OG004'}]}]}, {'title': 'HR-Day 7, Post dose, n=23,11,12,12,12', 'categories': [{'measurements': [{'value': '63.3', 'spread': '9.52', 'groupId': 'OG000'}, {'value': '60.9', 'spread': '9.27', 'groupId': 'OG001'}, {'value': '64.0', 'spread': '9.73', 'groupId': 'OG002'}, {'value': '62.2', 'spread': '7.88', 'groupId': 'OG003'}, {'value': '63.7', 'spread': '8.16', 'groupId': 'OG004'}]}]}, {'title': 'HR-Day 13, Pre saline, n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '62.5', 'spread': '7.17', 'groupId': 'OG000'}, {'value': '62.3', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '64.9', 'spread': '7.96', 'groupId': 'OG002'}, {'value': '62.3', 'spread': '8.54', 'groupId': 'OG003'}, {'value': '64.0', 'spread': '6.93', 'groupId': 'OG004'}]}]}, {'title': 'HR-Day 14, Pre challenge, n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '63.7', 'spread': '7.83', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '7.68', 'groupId': 'OG001'}, {'value': '64.9', 'spread': '5.12', 'groupId': 'OG002'}, {'value': '63.1', 'spread': '9.76', 'groupId': 'OG003'}, {'value': '62.1', 'spread': '6.58', 'groupId': 'OG004'}]}]}, {'title': 'HR-Day 14, 1h Post challenge, n=21,11,11,12,12', 'categories': [{'measurements': [{'value': '67.9', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '71.2', 'spread': '8.30', 'groupId': 'OG001'}, {'value': '69.7', 'spread': '8.22', 'groupId': 'OG002'}, {'value': '66.1', 'spread': '8.94', 'groupId': 'OG003'}, {'value': '67.6', 'spread': '5.60', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Participants were required to rest in the supine position for at least 10 minutes before each reading. Heart rate was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge) and Day 14 (pre and 1 hour post methacholine challenge).', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'D1,Pre dose,Nr,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'D1,Pre dose,ANCS,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'D1,Pre dose,ACS,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'D1,1h Post dose,Nr,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'D1,1h Post dose,ANCS,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'D1,1h Post dose,ACS,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'D14,Pre challenge,Nr,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'D14,Pre challenge,ANCS,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'D14,Pre challenge,ACS,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'D14,1h Post challenge,Nr,n=21,11,11,12,12', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}, {'title': 'D14,1h Post challenge,ANCS,n=21,11,11,12,12', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'D14,1h Post challenge,ACS,n=21,11,11,12,12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. It was measured on Day 1 (pre-dose and 1 hour post dose) and Day 14 (pre and 1 hour post methacholine challenge). Participants with normal (Nr), abnormal not clinically significant (ANCS) and abnormal clinically significant (ACS) ECG was presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1-allergen Challenge at Each Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'FEV1-5minutes, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.785', 'groupId': 'OG000', 'lowerLimit': '-0.945', 'upperLimit': '-0.626'}, {'value': '-0.765', 'groupId': 'OG001', 'lowerLimit': '-0.971', 'upperLimit': '-0.558'}, {'value': '-0.713', 'groupId': 'OG002', 'lowerLimit': '-0.933', 'upperLimit': '-0.493'}, {'value': '-0.565', 'groupId': 'OG003', 'lowerLimit': '-0.766', 'upperLimit': '-0.363'}, {'value': '-0.437', 'groupId': 'OG004', 'lowerLimit': '-0.639', 'upperLimit': '-0.234'}]}]}, {'title': 'FEV1-10minutes, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-1.077', 'groupId': 'OG000', 'lowerLimit': '-1.320', 'upperLimit': '-0.834'}, {'value': '-0.913', 'groupId': 'OG001', 'lowerLimit': '-1.202', 'upperLimit': '-0.625'}, {'value': '-1.026', 'groupId': 'OG002', 'lowerLimit': '-1.318', 'upperLimit': '-0.734'}, {'value': '-0.833', 'groupId': 'OG003', 'lowerLimit': '-1.116', 'upperLimit': '-0.549'}, {'value': '-0.583', 'groupId': 'OG004', 'lowerLimit': '-0.869', 'upperLimit': '-0.298'}]}]}, {'title': 'FEV1-15minutes, n=22,12,10,12,12', 'categories': [{'measurements': [{'value': '-1.182', 'groupId': 'OG000', 'lowerLimit': '-1.444', 'upperLimit': '-0.919'}, {'value': '-1.157', 'groupId': 'OG001', 'lowerLimit': '-1.478', 'upperLimit': '-0.837'}, {'value': '-1.039', 'groupId': 'OG002', 'lowerLimit': '-1.377', 'upperLimit': '-0.702'}, {'value': '-0.927', 'groupId': 'OG003', 'lowerLimit': '-1.240', 'upperLimit': '-0.614'}, {'value': '-0.682', 'groupId': 'OG004', 'lowerLimit': '-0.997', 'upperLimit': '-0.367'}]}]}, {'title': 'FEV1-20minutes, n=21,12,11,12,12', 'categories': [{'measurements': [{'value': '-1.238', 'groupId': 'OG000', 'lowerLimit': '-1.486', 'upperLimit': '-0.991'}, {'value': '-1.170', 'groupId': 'OG001', 'lowerLimit': '-1.473', 'upperLimit': '-0.867'}, {'value': '-1.144', 'groupId': 'OG002', 'lowerLimit': '-1.451', 'upperLimit': '-0.837'}, {'value': '-1.005', 'groupId': 'OG003', 'lowerLimit': '-1.301', 'upperLimit': '-0.709'}, {'value': '-0.666', 'groupId': 'OG004', 'lowerLimit': '-0.965', 'upperLimit': '-0.367'}]}]}, {'title': 'FEV1-30minutes, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-1.201', 'groupId': 'OG000', 'lowerLimit': '-1.480', 'upperLimit': '-0.921'}, {'value': '-1.212', 'groupId': 'OG001', 'lowerLimit': '-1.533', 'upperLimit': '-0.891'}, {'value': '-1.143', 'groupId': 'OG002', 'lowerLimit': '-1.467', 'upperLimit': '-0.819'}, {'value': '-0.982', 'groupId': 'OG003', 'lowerLimit': '-1.298', 'upperLimit': '-0.666'}, {'value': '-0.713', 'groupId': 'OG004', 'lowerLimit': '-1.031', 'upperLimit': '-0.395'}]}]}, {'title': 'FEV1-45minutes, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-1.048', 'groupId': 'OG000', 'lowerLimit': '-1.331', 'upperLimit': '-0.765'}, {'value': '-1.031', 'groupId': 'OG001', 'lowerLimit': '-1.361', 'upperLimit': '-0.701'}, {'value': '-0.983', 'groupId': 'OG002', 'lowerLimit': '-1.317', 'upperLimit': '-0.649'}, {'value': '-0.754', 'groupId': 'OG003', 'lowerLimit': '-1.079', 'upperLimit': '-0.429'}, {'value': '-0.667', 'groupId': 'OG004', 'lowerLimit': '-0.994', 'upperLimit': '-0.340'}]}]}, {'title': 'FEV1-1hour, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.865', 'groupId': 'OG000', 'lowerLimit': '-1.127', 'upperLimit': '-0.604'}, {'value': '-0.820', 'groupId': 'OG001', 'lowerLimit': '-1.122', 'upperLimit': '-0.517'}, {'value': '-0.882', 'groupId': 'OG002', 'lowerLimit': '-1.188', 'upperLimit': '-0.576'}, {'value': '-0.638', 'groupId': 'OG003', 'lowerLimit': '-0.936', 'upperLimit': '-0.340'}, {'value': '-0.523', 'groupId': 'OG004', 'lowerLimit': '-0.823', 'upperLimit': '-0.223'}]}]}, {'title': 'FEV1-1.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.541', 'groupId': 'OG000', 'lowerLimit': '-0.778', 'upperLimit': '-0.304'}, {'value': '-0.496', 'groupId': 'OG001', 'lowerLimit': '-0.767', 'upperLimit': '-0.225'}, {'value': '-0.523', 'groupId': 'OG002', 'lowerLimit': '-0.797', 'upperLimit': '-0.249'}, {'value': '-0.337', 'groupId': 'OG003', 'lowerLimit': '-0.604', 'upperLimit': '-0.069'}, {'value': '-0.323', 'groupId': 'OG004', 'lowerLimit': '-0.592', 'upperLimit': '-0.054'}]}]}, {'title': 'FEV1-2hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.311', 'groupId': 'OG000', 'lowerLimit': '-0.487', 'upperLimit': '-0.135'}, {'value': '-0.215', 'groupId': 'OG001', 'lowerLimit': '-0.427', 'upperLimit': '-0.002'}, {'value': '-0.459', 'groupId': 'OG002', 'lowerLimit': '-0.675', 'upperLimit': '-0.244'}, {'value': '-0.195', 'groupId': 'OG003', 'lowerLimit': '-0.403', 'upperLimit': '0.014'}, {'value': '-0.184', 'groupId': 'OG004', 'lowerLimit': '-0.395', 'upperLimit': '0.026'}]}]}, {'title': 'FEV1-2.5hours, n=21,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.165', 'groupId': 'OG000', 'lowerLimit': '-0.306', 'upperLimit': '-0.024'}, {'value': '-0.120', 'groupId': 'OG001', 'lowerLimit': '-0.290', 'upperLimit': '0.051'}, {'value': '-0.251', 'groupId': 'OG002', 'lowerLimit': '-0.424', 'upperLimit': '-0.077'}, {'value': '-0.138', 'groupId': 'OG003', 'lowerLimit': '-0.306', 'upperLimit': '0.029'}, {'value': '-0.107', 'groupId': 'OG004', 'lowerLimit': '-0.275', 'upperLimit': '0.061'}]}]}, {'title': 'FEV1-3hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.131', 'groupId': 'OG000', 'lowerLimit': '-0.268', 'upperLimit': '0.005'}, {'value': '-0.104', 'groupId': 'OG001', 'lowerLimit': '-0.274', 'upperLimit': '0.066'}, {'value': '-0.172', 'groupId': 'OG002', 'lowerLimit': '-0.344', 'upperLimit': '0.001'}, {'value': '-0.086', 'groupId': 'OG003', 'lowerLimit': '-0.252', 'upperLimit': '0.081'}, {'value': '-0.158', 'groupId': 'OG004', 'lowerLimit': '-0.326', 'upperLimit': '0.009'}]}]}, {'title': 'FEV1-3.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.184', 'groupId': 'OG000', 'lowerLimit': '-0.330', 'upperLimit': '-0.039'}, {'value': '-0.143', 'groupId': 'OG001', 'lowerLimit': '-0.324', 'upperLimit': '0.038'}, {'value': '-0.164', 'groupId': 'OG002', 'lowerLimit': '-0.348', 'upperLimit': '0.020'}, {'value': '-0.111', 'groupId': 'OG003', 'lowerLimit': '-0.288', 'upperLimit': '0.067'}, {'value': '-0.093', 'groupId': 'OG004', 'lowerLimit': '-0.272', 'upperLimit': '0.086'}]}]}, {'title': 'FEV1-4hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.196', 'groupId': 'OG000', 'lowerLimit': '-0.344', 'upperLimit': '-0.048'}, {'value': '-0.222', 'groupId': 'OG001', 'lowerLimit': '-0.409', 'upperLimit': '-0.036'}, {'value': '-0.201', 'groupId': 'OG002', 'lowerLimit': '-0.390', 'upperLimit': '-0.012'}, {'value': '-0.065', 'groupId': 'OG003', 'lowerLimit': '-0.247', 'upperLimit': '0.118'}, {'value': '-0.112', 'groupId': 'OG004', 'lowerLimit': '-0.296', 'upperLimit': '0.072'}]}]}, {'title': 'FEV1-4.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.341', 'groupId': 'OG000', 'lowerLimit': '-0.515', 'upperLimit': '-0.166'}, {'value': '-0.201', 'groupId': 'OG001', 'lowerLimit': '-0.418', 'upperLimit': '0.015'}, {'value': '-0.228', 'groupId': 'OG002', 'lowerLimit': '-0.448', 'upperLimit': '-0.008'}, {'value': '-0.137', 'groupId': 'OG003', 'lowerLimit': '-0.349', 'upperLimit': '0.076'}, {'value': '-0.091', 'groupId': 'OG004', 'lowerLimit': '-0.305', 'upperLimit': '0.123'}]}]}, {'title': 'FEV1-5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.376', 'groupId': 'OG000', 'lowerLimit': '-0.554', 'upperLimit': '-0.199'}, {'value': '-0.227', 'groupId': 'OG001', 'lowerLimit': '-0.439', 'upperLimit': '-0.016'}, {'value': '-0.246', 'groupId': 'OG002', 'lowerLimit': '-0.460', 'upperLimit': '-0.032'}, {'value': '-0.195', 'groupId': 'OG003', 'lowerLimit': '-0.403', 'upperLimit': '0.013'}, {'value': '-0.139', 'groupId': 'OG004', 'lowerLimit': '-0.348', 'upperLimit': '0.071'}]}]}, {'title': 'FEV1-5.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.394', 'groupId': 'OG000', 'lowerLimit': '-0.583', 'upperLimit': '-0.206'}, {'value': '-0.310', 'groupId': 'OG001', 'lowerLimit': '-0.534', 'upperLimit': '-0.086'}, {'value': '-0.401', 'groupId': 'OG002', 'lowerLimit': '-0.628', 'upperLimit': '-0.174'}, {'value': '-0.216', 'groupId': 'OG003', 'lowerLimit': '-0.437', 'upperLimit': '0.004'}, {'value': '-0.079', 'groupId': 'OG004', 'lowerLimit': '-0.301', 'upperLimit': '0.143'}]}]}, {'title': 'FEV1-6hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.519', 'groupId': 'OG000', 'lowerLimit': '-0.731', 'upperLimit': '-0.308'}, {'value': '-0.308', 'groupId': 'OG001', 'lowerLimit': '-0.559', 'upperLimit': '-0.056'}, {'value': '-0.342', 'groupId': 'OG002', 'lowerLimit': '-0.596', 'upperLimit': '-0.087'}, {'value': '-0.231', 'groupId': 'OG003', 'lowerLimit': '-0.478', 'upperLimit': '0.016'}, {'value': '-0.152', 'groupId': 'OG004', 'lowerLimit': '-0.401', 'upperLimit': '0.096'}]}]}, {'title': 'FEV1-6.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.528', 'groupId': 'OG000', 'lowerLimit': '-0.721', 'upperLimit': '-0.335'}, {'value': '-0.366', 'groupId': 'OG001', 'lowerLimit': '-0.598', 'upperLimit': '-0.135'}, {'value': '-0.393', 'groupId': 'OG002', 'lowerLimit': '-0.627', 'upperLimit': '-0.158'}, {'value': '-0.245', 'groupId': 'OG003', 'lowerLimit': '-0.472', 'upperLimit': '-0.018'}, {'value': '-0.167', 'groupId': 'OG004', 'lowerLimit': '-0.396', 'upperLimit': '0.062'}]}]}, {'title': 'FEV1-7hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.589', 'groupId': 'OG000', 'lowerLimit': '-0.796', 'upperLimit': '-0.381'}, {'value': '-0.366', 'groupId': 'OG001', 'lowerLimit': '-0.618', 'upperLimit': '-0.114'}, {'value': '-0.409', 'groupId': 'OG002', 'lowerLimit': '-0.665', 'upperLimit': '-0.153'}, {'value': '-0.202', 'groupId': 'OG003', 'lowerLimit': '-0.449', 'upperLimit': '0.045'}, {'value': '-0.222', 'groupId': 'OG004', 'lowerLimit': '-0.471', 'upperLimit': '0.027'}]}]}, {'title': 'FEV1-7.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.587', 'groupId': 'OG000', 'lowerLimit': '-0.803', 'upperLimit': '-0.372'}, {'value': '-0.403', 'groupId': 'OG001', 'lowerLimit': '-0.674', 'upperLimit': '-0.132'}, {'value': '-0.442', 'groupId': 'OG002', 'lowerLimit': '-0.717', 'upperLimit': '-0.166'}, {'value': '-0.216', 'groupId': 'OG003', 'lowerLimit': '-0.481', 'upperLimit': '0.050'}, {'value': '-0.163', 'groupId': 'OG004', 'lowerLimit': '-0.430', 'upperLimit': '0.104'}]}]}, {'title': 'FEV1-8hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.648', 'groupId': 'OG000', 'lowerLimit': '-0.866', 'upperLimit': '-0.431'}, {'value': '-0.401', 'groupId': 'OG001', 'lowerLimit': '-0.662', 'upperLimit': '-0.141'}, {'value': '-0.481', 'groupId': 'OG002', 'lowerLimit': '-0.745', 'upperLimit': '-0.216'}, {'value': '-0.191', 'groupId': 'OG003', 'lowerLimit': '-0.447', 'upperLimit': '0.065'}, {'value': '-0.092', 'groupId': 'OG004', 'lowerLimit': '-0.350', 'upperLimit': '0.166'}]}]}, {'title': 'FEV1-8.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.668', 'groupId': 'OG000', 'lowerLimit': '-0.892', 'upperLimit': '-0.443'}, {'value': '-0.423', 'groupId': 'OG001', 'lowerLimit': '-0.699', 'upperLimit': '-0.148'}, {'value': '-0.446', 'groupId': 'OG002', 'lowerLimit': '-0.725', 'upperLimit': '-0.167'}, {'value': '-0.158', 'groupId': 'OG003', 'lowerLimit': '-0.428', 'upperLimit': '0.112'}, {'value': '-0.075', 'groupId': 'OG004', 'lowerLimit': '-0.347', 'upperLimit': '0.197'}]}]}, {'title': 'FEV1-9hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.652', 'groupId': 'OG000', 'lowerLimit': '-0.878', 'upperLimit': '-0.427'}, {'value': '-0.498', 'groupId': 'OG001', 'lowerLimit': '-0.765', 'upperLimit': '-0.231'}, {'value': '-0.509', 'groupId': 'OG002', 'lowerLimit': '-0.780', 'upperLimit': '-0.238'}, {'value': '-0.160', 'groupId': 'OG003', 'lowerLimit': '-0.423', 'upperLimit': '0.103'}, {'value': '-0.093', 'groupId': 'OG004', 'lowerLimit': '-0.358', 'upperLimit': '0.172'}]}]}, {'title': 'FEV1-9.5hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.660', 'groupId': 'OG000', 'lowerLimit': '-0.891', 'upperLimit': '-0.430'}, {'value': '-0.485', 'groupId': 'OG001', 'lowerLimit': '-0.750', 'upperLimit': '-0.221'}, {'value': '-0.473', 'groupId': 'OG002', 'lowerLimit': '-0.740', 'upperLimit': '-0.205'}, {'value': '-0.246', 'groupId': 'OG003', 'lowerLimit': '-0.507', 'upperLimit': '0.015'}, {'value': '-0.139', 'groupId': 'OG004', 'lowerLimit': '-0.401', 'upperLimit': '0.124'}]}]}, {'title': 'FEV1-10hours, n=22,12,11,12,12', 'categories': [{'measurements': [{'value': '-0.646', 'groupId': 'OG000', 'lowerLimit': '-0.875', 'upperLimit': '-0.418'}, {'value': '-0.562', 'groupId': 'OG001', 'lowerLimit': '-0.821', 'upperLimit': '-0.302'}, {'value': '-0.478', 'groupId': 'OG002', 'lowerLimit': '-0.740', 'upperLimit': '-0.216'}, {'value': '-0.206', 'groupId': 'OG003', 'lowerLimit': '-0.462', 'upperLimit': '0.050'}, {'value': '-0.133', 'groupId': 'OG004', 'lowerLimit': '-0.390', 'upperLimit': '0.125'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.021', 'ciLowerLimit': '-0.199', 'ciUpperLimit': '0.240', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1086', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.164', 'ciLowerLimit': '-0.096', 'ciUpperLimit': '0.424', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1285', 'estimateComment': 'Comparison of FEV1 between placebo and 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'ciPctValue': '95', 'paramValue': '-0.011', 'ciLowerLimit': '-0.277', 'ciUpperLimit': '0.254', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1313', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 30 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.016', 'ciLowerLimit': '-0.269', 'ciUpperLimit': '0.302', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1410', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 45 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.046', 'ciLowerLimit': '-0.210', 'ciUpperLimit': '0.301', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1265', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.045', 'ciLowerLimit': '-0.178', 'ciUpperLimit': '0.268', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1102', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 1.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.096', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '0.295', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0985', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.045', 'ciLowerLimit': '-0.121', 'ciUpperLimit': '0.212', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0826', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 2.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.027', 'ciLowerLimit': '-0.141', 'ciUpperLimit': '0.196', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0832', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.042', 'ciLowerLimit': '-0.138', 'ciUpperLimit': '0.221', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0888', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 3.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.027', 'ciLowerLimit': '-0.215', 'ciUpperLimit': '0.162', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0934', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.139', 'ciLowerLimit': '-0.076', 'ciUpperLimit': '0.354', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1065', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 4.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.149', 'ciLowerLimit': '-0.044', 'ciUpperLimit': '0.342', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0955', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.084', 'ciLowerLimit': '-0.119', 'ciUpperLimit': '0.288', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1005', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 5.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.212', 'ciLowerLimit': '-0.015', 'ciUpperLimit': '0.438', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1122', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.162', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.374', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1051', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 6.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.222', 'ciLowerLimit': '-0.017', 'ciUpperLimit': '0.461', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1181', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.185', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '0.458', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1355', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 7.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.247', 'ciLowerLimit': '0.007', 'ciUpperLimit': '0.487', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1187', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.244', 'ciLowerLimit': '-0.021', 'ciUpperLimit': '0.509', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1313', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 8.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.154', 'ciLowerLimit': '-0.086', 'ciUpperLimit': '0.394', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1189', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.175', 'ciLowerLimit': '-0.044', 'ciUpperLimit': '0.394', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1085', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at 9.5 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'0.051', 'ciLowerLimit': '-0.213', 'ciUpperLimit': '0.314', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1303', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.142', 'ciLowerLimit': '-0.176', 'ciUpperLimit': '0.461', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1572', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 15 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.094', 'ciLowerLimit': '-0.208', 'ciUpperLimit': '0.396', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1494', 'estimateComment': 'Comparison of FEV1 between placebo and 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'95', 'paramValue': '-0.016', 'ciLowerLimit': '-0.276', 'ciUpperLimit': '0.243', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1283', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 1 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.017', 'ciLowerLimit': '-0.209', 'ciUpperLimit': '0.244', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1118', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 1.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.148', 'ciLowerLimit': '-0.350', 'ciUpperLimit': '0.053', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0998', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.086', 'ciLowerLimit': '-0.253', 'ciUpperLimit': '0.082', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0829', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 2.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.040', 'ciLowerLimit': '-0.211', 'ciUpperLimit': '0.130', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0843', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 3 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.161', 'ciUpperLimit': '0.202', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0900', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 3.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.005', 'ciLowerLimit': '-0.196', 'ciUpperLimit': '0.186', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0947', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 4 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.113', 'ciLowerLimit': '-0.105', 'ciUpperLimit': '0.330', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1079', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 4.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.130', 'ciLowerLimit': '-0.065', 'ciUpperLimit': '0.326', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0968', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.007', 'ciLowerLimit': '-0.213', 'ciUpperLimit': '0.199', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1019', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 5.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.178', 'ciLowerLimit': '-0.052', 'ciUpperLimit': '0.407', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1138', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 6 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.135', 'ciLowerLimit': '-0.080', 'ciUpperLimit': '0.351', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1065', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 6.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.179', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.421', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1198', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 7 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.146', 'ciLowerLimit': '-0.131', 'ciUpperLimit': '0.423', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1373', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 7.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.168', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.411', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1203', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 8 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.222', 'ciLowerLimit': '-0.047', 'ciUpperLimit': '0.490', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1331', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 8.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.143', 'ciLowerLimit': '-0.100', 'ciUpperLimit': '0.387', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1206', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.187', 'ciLowerLimit': '-0.035', 'ciUpperLimit': '0.410', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1100', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 9.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.168', 'ciLowerLimit': '-0.042', 'ciUpperLimit': '0.378', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1039', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at 10 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.221', 'ciLowerLimit': '0.011', 'ciUpperLimit': '0.431', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1036', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.244', 'ciLowerLimit': '-0.006', 'ciUpperLimit': '0.494', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1236', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.255', 'ciLowerLimit': '-0.038', 'ciUpperLimit': '0.548', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1445', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 15 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.233', 'ciLowerLimit': '-0.057', 'ciUpperLimit': '0.524', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1436', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 20 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.219', 'ciLowerLimit': '-0.036', 'ciUpperLimit': '0.474', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1262', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 30 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.294', 'ciLowerLimit': '0.019', 'ciUpperLimit': '0.568', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1355', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 45 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.227', 'ciLowerLimit': '-0.019', 'ciUpperLimit': '0.473', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1216', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 1 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.204', 'ciLowerLimit': '-0.010', 'ciUpperLimit': '0.418', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1059', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 1.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.116', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.308', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0947', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.027', 'ciLowerLimit': '-0.136', 'ciUpperLimit': '0.190', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0805', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 2.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.046', 'ciLowerLimit': '-0.116', 'ciUpperLimit': '0.208', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0801', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 3 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.074', 'ciLowerLimit': '-0.099', 'ciUpperLimit': '0.247', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0855', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 3.5 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.131', 'ciLowerLimit': '-0.051', 'ciUpperLimit': '0.313', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0900', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 4 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.204', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.411', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1025', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 4.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.181', 'ciLowerLimit': '-0.004', 'ciUpperLimit': '0.367', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0918', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.178', 'ciLowerLimit': '-0.018', 'ciUpperLimit': '0.373', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0967', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 5.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.288', 'ciLowerLimit': '0.070', 'ciUpperLimit': '0.506', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1079', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 6 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.283', 'ciLowerLimit': '0.079', 'ciUpperLimit': '0.488', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1011', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 6.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.386', 'ciLowerLimit': '0.157', 'ciUpperLimit': '0.616', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1137', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 7 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.372', 'ciLowerLimit': '0.108', 'ciUpperLimit': '0.636', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1306', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 7.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.458', 'ciLowerLimit': '0.227', 'ciUpperLimit': '0.688', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1142', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 8 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.509', 'ciLowerLimit': '0.254', 'ciUpperLimit': '0.765', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1264', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 8.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.492', 'ciLowerLimit': '0.261', 'ciUpperLimit': '0.723', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1144', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.414', 'ciLowerLimit': '0.203', 'ciUpperLimit': '0.625', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1042', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 9.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.440', 'ciLowerLimit': '0.241', 'ciUpperLimit': '0.639', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0984', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at 10 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.348', 'ciLowerLimit': '0.135', 'ciUpperLimit': '0.562', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1056', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.494', 'ciLowerLimit': '0.237', 'ciUpperLimit': '0.751', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1273', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.499', 'ciLowerLimit': '0.199', 'ciUpperLimit': '0.800', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1484', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 15 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.573', 'ciLowerLimit': '0.274', 'ciUpperLimit': '0.872', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1481', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 20 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.488', 'ciLowerLimit': '0.225', 'ciUpperLimit': '0.751', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1303', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 30 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.380', 'ciLowerLimit': '0.098', 'ciUpperLimit': '0.663', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1398', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 45 minutes', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.342', 'ciLowerLimit': '0.089', 'ciUpperLimit': '0.596', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1254', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.218', 'ciLowerLimit': '-0.003', 'ciUpperLimit': '0.439', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1094', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 1.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.127', 'ciLowerLimit': '-0.070', 'ciUpperLimit': '0.323', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0974', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.058', 'ciLowerLimit': '-0.107', 'ciUpperLimit': '0.223', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0818', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 2.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.027', 'ciLowerLimit': '-0.192', 'ciUpperLimit': '0.139', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0821', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.091', 'ciLowerLimit': '-0.085', 'ciUpperLimit': '0.268', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0876', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 3.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.084', 'ciLowerLimit': '-0.102', 'ciUpperLimit': '0.269', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0921', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.249', 'ciLowerLimit': '0.038', 'ciUpperLimit': '0.461', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1050', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 4.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.238', 'ciLowerLimit': '0.047', 'ciUpperLimit': '0.429', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0945', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.315', 'ciLowerLimit': '0.114', 'ciUpperLimit': '0.516', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0995', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 5.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.367', 'ciLowerLimit': '0.143', 'ciUpperLimit': '0.591', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1111', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.361', 'ciLowerLimit': '0.151', 'ciUpperLimit': '0.571', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1040', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 6.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.367', 'ciLowerLimit': '0.131', 'ciUpperLimit': '0.602', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1168', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7 hour', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.424', 'ciLowerLimit': '0.155', 'ciUpperLimit': '0.694', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1336', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 7.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.556', 'ciLowerLimit': '0.319', 'ciUpperLimit': '0.793', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1174', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.593', 'ciLowerLimit': '0.331', 'ciUpperLimit': '0.854', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1297', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 8.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.559', 'ciLowerLimit': '0.322', 'ciUpperLimit': '0.797', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1177', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.522', 'ciLowerLimit': '0.304', 'ciUpperLimit': '0.739', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1076', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 9.5 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.514', 'ciLowerLimit': '0.308', 'ciUpperLimit': '0.719', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1017', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at 10 hours', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to Day 13 of each treatment period (approximately 17 weeks)', 'description': 'A mixed model analysis was performed separately for each planned time point during the allergen challenge on Day 13, from 5 minutes to 10 hour, including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. FEV1 was measured at 5, 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours. The adjusted mean is presented as LSM.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed (represented by n=x,x,x,x,x in the category titles).'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Basophils,Day1,pre-dose', 'categories': [{'measurements': [{'value': '0.027', 'spread': '0.0123', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.0117', 'groupId': 'OG001'}, {'value': '0.022', 'spread': '0.0094', 'groupId': 'OG002'}, {'value': '0.016', 'spread': '0.0090', 'groupId': 'OG003'}, {'value': '0.021', 'spread': '0.0079', 'groupId': 'OG004'}]}]}, {'title': 'Basophils,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '0.021', 'spread': '0.0118', 'groupId': 'OG000'}, {'value': '0.020', 'spread': '0.0113', 'groupId': 'OG001'}, {'value': '0.027', 'spread': '0.0107', 'groupId': 'OG002'}, {'value': '0.018', 'spread': '0.0094', 'groupId': 'OG003'}, {'value': '0.023', 'spread': '0.0089', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils,Day1,pre-dose', 'categories': [{'measurements': [{'value': '0.417', 'spread': '0.2395', 'groupId': 'OG000'}, {'value': '0.289', 'spread': '0.1451', 'groupId': 'OG001'}, {'value': '0.429', 'spread': '0.2930', 'groupId': 'OG002'}, {'value': '0.308', 'spread': '0.1579', 'groupId': 'OG003'}, {'value': '0.459', 'spread': '0.3528', 'groupId': 'OG004'}]}]}, {'title': 'Eosinophils,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '0.516', 'spread': '0.2579', 'groupId': 'OG000'}, {'value': '0.411', 'spread': '0.1399', 'groupId': 'OG001'}, {'value': '0.482', 'spread': '0.2291', 'groupId': 'OG002'}, {'value': '0.320', 'spread': '0.1587', 'groupId': 'OG003'}, {'value': '0.346', 'spread': '0.2143', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,Day1,pre-dose', 'categories': [{'measurements': [{'value': '1.792', 'spread': '0.5462', 'groupId': 'OG000'}, {'value': '1.948', 'spread': '0.4525', 'groupId': 'OG001'}, {'value': '2.100', 'spread': '0.6834', 'groupId': 'OG002'}, {'value': '1.688', 'spread': '0.4350', 'groupId': 'OG003'}, {'value': '1.574', 'spread': '0.3542', 'groupId': 'OG004'}]}]}, {'title': 'Lymphocytes,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '1.676', 'spread': '0.4461', 'groupId': 'OG000'}, {'value': '1.872', 'spread': '0.4693', 'groupId': 'OG001'}, {'value': '1.771', 'spread': '0.4827', 'groupId': 'OG002'}, {'value': '1.599', 'spread': '0.5361', 'groupId': 'OG003'}, {'value': '1.619', 'spread': '0.3474', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes,Day1,pre-dose', 'categories': [{'measurements': [{'value': '0.384', 'spread': '0.1283', 'groupId': 'OG000'}, {'value': '0.393', 'spread': '0.1277', 'groupId': 'OG001'}, {'value': '0.340', 'spread': '0.1041', 'groupId': 'OG002'}, {'value': '0.329', 'spread': '0.0598', 'groupId': 'OG003'}, {'value': '0.338', 'spread': '0.1024', 'groupId': 'OG004'}]}]}, {'title': 'Monocytes,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '0.362', 'spread': '0.0909', 'groupId': 'OG000'}, {'value': '0.378', 'spread': '0.1100', 'groupId': 'OG001'}, {'value': '0.382', 'spread': '0.1712', 'groupId': 'OG002'}, {'value': '0.355', 'spread': '0.1313', 'groupId': 'OG003'}, {'value': '0.364', 'spread': '0.1125', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils,Day1,pre-dose', 'categories': [{'measurements': [{'value': '3.258', 'spread': '1.1745', 'groupId': 'OG000'}, {'value': '3.829', 'spread': '1.7236', 'groupId': 'OG001'}, {'value': '2.966', 'spread': '1.1941', 'groupId': 'OG002'}, {'value': '2.811', 'spread': '0.4711', 'groupId': 'OG003'}, {'value': '3.251', 'spread': '1.1947', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '3.572', 'spread': '1.4247', 'groupId': 'OG000'}, {'value': '3.209', 'spread': '0.8137', 'groupId': 'OG001'}, {'value': '3.557', 'spread': '1.3102', 'groupId': 'OG002'}, {'value': '3.182', 'spread': '0.7059', 'groupId': 'OG003'}, {'value': '3.288', 'spread': '1.0353', 'groupId': 'OG004'}]}]}, {'title': 'Platelet,Day1,pre-dose', 'categories': [{'measurements': [{'value': '233.9', 'spread': '35.20', 'groupId': 'OG000'}, {'value': '240.3', 'spread': '42.02', 'groupId': 'OG001'}, {'value': '247.3', 'spread': '47.10', 'groupId': 'OG002'}, {'value': '229.6', 'spread': '28.27', 'groupId': 'OG003'}, {'value': '238.8', 'spread': '51.34', 'groupId': 'OG004'}]}]}, {'title': 'Platelet,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '230.3', 'spread': '31.03', 'groupId': 'OG000'}, {'value': '220.3', 'spread': '28.04', 'groupId': 'OG001'}, {'value': '230.4', 'spread': '24.21', 'groupId': 'OG002'}, {'value': '229.0', 'spread': '30.64', 'groupId': 'OG003'}, {'value': '220.8', 'spread': '33.76', 'groupId': 'OG004'}]}]}, {'title': 'WBC,Day1,pre-dose', 'categories': [{'measurements': [{'value': '5.88', 'spread': '1.598', 'groupId': 'OG000'}, {'value': '6.48', 'spread': '1.582', 'groupId': 'OG001'}, {'value': '5.86', 'spread': '1.405', 'groupId': 'OG002'}, {'value': '5.15', 'spread': '0.672', 'groupId': 'OG003'}, {'value': '5.64', 'spread': '1.439', 'groupId': 'OG004'}]}]}, {'title': 'WBC,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '6.15', 'spread': '1.865', 'groupId': 'OG000'}, {'value': '5.89', 'spread': '1.124', 'groupId': 'OG001'}, {'value': '6.22', 'spread': '1.681', 'groupId': 'OG002'}, {'value': '5.48', 'spread': '1.008', 'groupId': 'OG003'}, {'value': '5.64', 'spread': '1.158', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Giga cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in FEV1-non Allergen Challenge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'FEV1,Day 7,n=23,11,12,12,12', 'categories': [{'measurements': [{'value': '-0.110', 'groupId': 'OG000', 'lowerLimit': '-0.229', 'upperLimit': '0.010'}, {'value': '0.185', 'groupId': 'OG001', 'lowerLimit': '0.006', 'upperLimit': '0.364'}, {'value': '0.221', 'groupId': 'OG002', 'lowerLimit': '0.054', 'upperLimit': '0.387'}, {'value': '0.187', 'groupId': 'OG003', 'lowerLimit': '0.021', 'upperLimit': '0.353'}, {'value': '0.213', 'groupId': 'OG004', 'lowerLimit': '0.046', 'upperLimit': '0.380'}]}]}, {'title': 'FEV1,Day 13,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '0.027', 'groupId': 'OG000', 'lowerLimit': '-0.095', 'upperLimit': '0.149'}, {'value': '0.212', 'groupId': 'OG001', 'lowerLimit': '0.046', 'upperLimit': '0.378'}, {'value': '0.108', 'groupId': 'OG002', 'lowerLimit': '-0.055', 'upperLimit': '0.270'}, {'value': '0.283', 'groupId': 'OG003', 'lowerLimit': '0.120', 'upperLimit': '0.445'}, {'value': '0.256', 'groupId': 'OG004', 'lowerLimit': '0.093', 'upperLimit': '0.419'}]}]}, {'title': 'FEV1,Day 14,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '-0.325', 'groupId': 'OG000', 'lowerLimit': '-0.468', 'upperLimit': '-0.182'}, {'value': '-0.181', 'groupId': 'OG001', 'lowerLimit': '-0.372', 'upperLimit': '0.011'}, {'value': '-0.199', 'groupId': 'OG002', 'lowerLimit': '-0.387', 'upperLimit': '-0.011'}, {'value': '0.137', 'groupId': 'OG003', 'lowerLimit': '-0.050', 'upperLimit': '0.324'}, {'value': '0.047', 'groupId': 'OG004', 'lowerLimit': '-0.141', 'upperLimit': '0.235'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciPctValue': '95', 'paramValue': '0.295', 'ciLowerLimit': '0.086', 'ciUpperLimit': '0.503', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1038', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.185', 'ciLowerLimit': '0.007', 'ciUpperLimit': '0.363', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0884', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 13', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.144', 'ciLowerLimit': '-0.062', 'ciUpperLimit': '0.351', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1026', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 0.25 mg OD at Day 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.330', 'ciLowerLimit': '0.133', 'ciUpperLimit': '0.527', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0979', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.081', 'ciLowerLimit': '-0.092', 'ciUpperLimit': '0.253', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0856', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 13', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.126', 'ciLowerLimit': '-0.076', 'ciUpperLimit': '0.327', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1000', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 1 mg OD at Day 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.297', 'ciLowerLimit': '0.100', 'ciUpperLimit': '0.493', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0976', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.256', 'ciLowerLimit': '0.083', 'ciUpperLimit': '0.429', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0859', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 13', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.462', 'ciLowerLimit': '0.262', 'ciUpperLimit': '0.662', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0991', 'estimateComment': 'Comparison of FEV1 between placebo and GW870086 3 mg OD at Day 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.323', 'ciLowerLimit': '0.125', 'ciUpperLimit': '0.520', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0982', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.229', 'ciLowerLimit': '0.057', 'ciUpperLimit': '0.402', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0858', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 13', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.372', 'ciLowerLimit': '0.172', 'ciUpperLimit': '0.572', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0991', 'estimateComment': 'Comparison of FEV1 between placebo and fluticasone propionate 0.25 mg BID at Day 14', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Non-allergen challenge FEV1 data was measured on Day 1, 7, 13 and 14. The FEV1 assessments on Day 1 was taken at pre-dose and those on Day 7 was taken post-dose. On Day 13, the pre-allergen challenge FEV1 values was used and on Day 14 the pre-methacholine challenge FEV1 values was used. Absolute change in FEV1 on Day 7, 13 and 14 from pre-dose FEV1 was analyzed separately using a mixed-effects ANOVA model. Period-level Baseline was defined as the difference between the Day 1 pre-dose value and participant-level Baseline for each period, each participant. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value. Post-randomization values refer to assessments performed post dose and after the Baseline assessment. The adjusted mean is presented as LSM.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Hemoglobin,Day1,pre-dose', 'categories': [{'measurements': [{'value': '149.0', 'spread': '9.04', 'groupId': 'OG000'}, {'value': '151.8', 'spread': '7.58', 'groupId': 'OG001'}, {'value': '147.1', 'spread': '10.01', 'groupId': 'OG002'}, {'value': '145.2', 'spread': '6.52', 'groupId': 'OG003'}, {'value': '147.2', 'spread': '6.01', 'groupId': 'OG004'}]}]}, {'title': 'Hemoglobin,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '147.1', 'spread': '10.16', 'groupId': 'OG000'}, {'value': '150.3', 'spread': '10.23', 'groupId': 'OG001'}, {'value': '148.6', 'spread': '9.79', 'groupId': 'OG002'}, {'value': '140.8', 'spread': '9.11', 'groupId': 'OG003'}, {'value': '147.4', 'spread': '8.14', 'groupId': 'OG004'}]}]}, {'title': 'MCHC,Day1,pre-dose', 'categories': [{'measurements': [{'value': '335.0', 'spread': '5.43', 'groupId': 'OG000'}, {'value': '335.9', 'spread': '6.04', 'groupId': 'OG001'}, {'value': '336.3', 'spread': '5.74', 'groupId': 'OG002'}, {'value': '334.6', 'spread': '7.24', 'groupId': 'OG003'}, {'value': '336.3', 'spread': '4.23', 'groupId': 'OG004'}]}]}, {'title': 'MCHC,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '335.7', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '335.8', 'spread': '5.80', 'groupId': 'OG001'}, {'value': '337.9', 'spread': '5.73', 'groupId': 'OG002'}, {'value': '333.5', 'spread': '5.57', 'groupId': 'OG003'}, {'value': '335.7', 'spread': '6.64', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Hematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Hematocrit,Day1,pre-dose', 'categories': [{'measurements': [{'value': '0.4445', 'spread': '0.02631', 'groupId': 'OG000'}, {'value': '0.4519', 'spread': '0.02474', 'groupId': 'OG001'}, {'value': '0.4369', 'spread': '0.02850', 'groupId': 'OG002'}, {'value': '0.4341', 'spread': '0.01919', 'groupId': 'OG003'}, {'value': '0.4376', 'spread': '0.02114', 'groupId': 'OG004'}]}]}, {'title': 'Hematocrit,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '0.4383', 'spread': '0.02929', 'groupId': 'OG000'}, {'value': '0.4476', 'spread': '0.03070', 'groupId': 'OG001'}, {'value': '0.4396', 'spread': '0.02950', 'groupId': 'OG002'}, {'value': '0.4225', 'spread': '0.02418', 'groupId': 'OG003'}, {'value': '0.4391', 'spread': '0.02880', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'MCH,Day1,pre-dose', 'categories': [{'measurements': [{'value': '30.84', 'spread': '1.473', 'groupId': 'OG000'}, {'value': '31.23', 'spread': '1.577', 'groupId': 'OG001'}, {'value': '30.93', 'spread': '1.652', 'groupId': 'OG002'}, {'value': '30.86', 'spread': '1.053', 'groupId': 'OG003'}, {'value': '30.58', 'spread': '1.652', 'groupId': 'OG004'}]}]}, {'title': 'MCH,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '30.87', 'spread': '1.512', 'groupId': 'OG000'}, {'value': '31.19', 'spread': '1.576', 'groupId': 'OG001'}, {'value': '30.92', 'spread': '1.634', 'groupId': 'OG002'}, {'value': '30.89', 'spread': '0.961', 'groupId': 'OG003'}, {'value': '30.57', 'spread': '1.629', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Picograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Mean Corpuscle Volume (MCV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'MCV,Day1,pre-dose', 'categories': [{'measurements': [{'value': '92.1', 'spread': '4.87', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '4.43', 'groupId': 'OG001'}, {'value': '92.0', 'spread': '4.57', 'groupId': 'OG002'}, {'value': '92.3', 'spread': '2.96', 'groupId': 'OG003'}, {'value': '91.0', 'spread': '5.39', 'groupId': 'OG004'}]}]}, {'title': 'MCV,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '92.0', 'spread': '4.53', 'groupId': 'OG000'}, {'value': '93.0', 'spread': '3.84', 'groupId': 'OG001'}, {'value': '91.5', 'spread': '4.42', 'groupId': 'OG002'}, {'value': '92.8', 'spread': '2.89', 'groupId': 'OG003'}, {'value': '91.2', 'spread': '5.52', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Femtoliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Reticulocytes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Reticulocytes,Day1,pre-dose', 'categories': [{'measurements': [{'value': '0.04626', 'spread': '0.027363', 'groupId': 'OG000'}, {'value': '0.04708', 'spread': '0.026433', 'groupId': 'OG001'}, {'value': '0.04941', 'spread': '0.027213', 'groupId': 'OG002'}, {'value': '0.05176', 'spread': '0.016041', 'groupId': 'OG003'}, {'value': '0.05268', 'spread': '0.017560', 'groupId': 'OG004'}]}]}, {'title': 'Reticulocytes,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '0.04574', 'spread': '0.016707', 'groupId': 'OG000'}, {'value': '0.05613', 'spread': '0.026415', 'groupId': 'OG001'}, {'value': '0.04720', 'spread': '0.020698', 'groupId': 'OG002'}, {'value': '0.04565', 'spread': '0.017335', 'groupId': 'OG003'}, {'value': '0.05543', 'spread': '0.029142', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Trillion cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Albumin and Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Albumin,Day1,pre-dose', 'categories': [{'measurements': [{'value': '45.4', 'spread': '2.41', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '2.94', 'groupId': 'OG001'}, {'value': '45.2', 'spread': '2.98', 'groupId': 'OG002'}, {'value': '45.7', 'spread': '2.23', 'groupId': 'OG003'}, {'value': '45.3', 'spread': '3.42', 'groupId': 'OG004'}]}]}, {'title': 'Albumin,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '44.5', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '2.15', 'groupId': 'OG001'}, {'value': '44.6', 'spread': '2.43', 'groupId': 'OG002'}, {'value': '44.6', 'spread': '1.73', 'groupId': 'OG003'}, {'value': '44.8', 'spread': '2.25', 'groupId': 'OG004'}]}]}, {'title': 'Total protein,Day1,pre-dose', 'categories': [{'measurements': [{'value': '70.6', 'spread': '3.48', 'groupId': 'OG000'}, {'value': '71.3', 'spread': '3.96', 'groupId': 'OG001'}, {'value': '68.8', 'spread': '2.80', 'groupId': 'OG002'}, {'value': '70.0', 'spread': '3.10', 'groupId': 'OG003'}, {'value': '70.6', 'spread': '2.81', 'groupId': 'OG004'}]}]}, {'title': 'Total protein,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '69.3', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '69.6', 'spread': '3.20', 'groupId': 'OG001'}, {'value': '67.8', 'spread': '3.01', 'groupId': 'OG002'}, {'value': '68.2', 'spread': '3.76', 'groupId': 'OG003'}, {'value': '69.6', 'spread': '3.03', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'ALP,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '60.8', 'spread': '15.08', 'groupId': 'OG000'}, {'value': '61.5', 'spread': '11.12', 'groupId': 'OG001'}, {'value': '57.3', 'spread': '15.03', 'groupId': 'OG002'}, {'value': '54.6', 'spread': '18.08', 'groupId': 'OG003'}, {'value': '64.1', 'spread': '11.33', 'groupId': 'OG004'}]}]}, {'title': 'ALP,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '58.8', 'spread': '14.52', 'groupId': 'OG000'}, {'value': '61.2', 'spread': '13.71', 'groupId': 'OG001'}, {'value': '55.6', 'spread': '14.64', 'groupId': 'OG002'}, {'value': '53.3', 'spread': '17.39', 'groupId': 'OG003'}, {'value': '63.7', 'spread': '9.70', 'groupId': 'OG004'}]}]}, {'title': 'ALT,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '20.6', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '17.8', 'spread': '7.72', 'groupId': 'OG001'}, {'value': '18.9', 'spread': '5.37', 'groupId': 'OG002'}, {'value': '17.6', 'spread': '7.32', 'groupId': 'OG003'}, {'value': '21.3', 'spread': '5.90', 'groupId': 'OG004'}]}]}, {'title': 'ALT,Day7,pre-dose,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '19.6', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '7.45', 'groupId': 'OG001'}, {'value': '19.5', 'spread': '6.23', 'groupId': 'OG002'}, {'value': '17.4', 'spread': '6.88', 'groupId': 'OG003'}, {'value': '18.7', 'spread': '4.16', 'groupId': 'OG004'}]}]}, {'title': 'ALT,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '18.3', 'spread': '7.83', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '7.06', 'groupId': 'OG001'}, {'value': '18.4', 'spread': '4.10', 'groupId': 'OG002'}, {'value': '16.8', 'spread': '8.16', 'groupId': 'OG003'}, {'value': '20.3', 'spread': '5.77', 'groupId': 'OG004'}]}]}, {'title': 'AST,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '21.3', 'spread': '6.01', 'groupId': 'OG000'}, {'value': '19.1', 'spread': '4.50', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '3.80', 'groupId': 'OG002'}, {'value': '19.3', 'spread': '5.93', 'groupId': 'OG003'}, {'value': '23.8', 'spread': '5.42', 'groupId': 'OG004'}]}]}, {'title': 'AST,Day7,pre-dose,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '20.1', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '4.93', 'groupId': 'OG001'}, {'value': '20.0', 'spread': '3.69', 'groupId': 'OG002'}, {'value': '18.7', 'spread': '4.12', 'groupId': 'OG003'}, {'value': '20.3', 'spread': '3.60', 'groupId': 'OG004'}]}]}, {'title': 'AST,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '18.5', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '4.72', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '3.92', 'groupId': 'OG002'}, {'value': '17.8', 'spread': '4.65', 'groupId': 'OG003'}, {'value': '21.1', 'spread': '5.16', 'groupId': 'OG004'}]}]}, {'title': 'GGT,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '30.0', 'spread': '22.30', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '14.98', 'groupId': 'OG001'}, {'value': '25.9', 'spread': '7.69', 'groupId': 'OG002'}, {'value': '24.5', 'spread': '18.25', 'groupId': 'OG003'}, {'value': '31.5', 'spread': '19.76', 'groupId': 'OG004'}]}]}, {'title': 'GGT,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '28.8', 'spread': '17.64', 'groupId': 'OG000'}, {'value': '28.3', 'spread': '13.94', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '6.95', 'groupId': 'OG002'}, {'value': '23.3', 'spread': '15.77', 'groupId': 'OG003'}, {'value': '31.1', 'spread': '19.78', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Liver safety parameters (ALT and AST) were also assessed on Day 7 (pre-dose).', 'unitOfMeasure': 'International unit per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'TB,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '13.7', 'spread': '7.06', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '6.08', 'groupId': 'OG001'}, {'value': '12.6', 'spread': '5.50', 'groupId': 'OG002'}, {'value': '11.8', 'spread': '2.90', 'groupId': 'OG003'}, {'value': '14.7', 'spread': '5.50', 'groupId': 'OG004'}]}]}, {'title': 'TB,Day7,pre-dose,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '11.3', 'spread': '5.18', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '6.24', 'groupId': 'OG001'}, {'value': '11.8', 'spread': '5.24', 'groupId': 'OG002'}, {'value': '10.3', 'spread': '4.29', 'groupId': 'OG003'}, {'value': '12.6', 'spread': '5.43', 'groupId': 'OG004'}]}]}, {'title': 'TB,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '11.4', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '5.81', 'groupId': 'OG001'}, {'value': '12.7', 'spread': '5.99', 'groupId': 'OG002'}, {'value': '11.5', 'spread': '4.54', 'groupId': 'OG003'}, {'value': '11.7', 'spread': '4.87', 'groupId': 'OG004'}]}]}, {'title': 'DB,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.09', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '0.97', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '0.74', 'groupId': 'OG003'}, {'value': '2.5', 'spread': '1.17', 'groupId': 'OG004'}]}]}, {'title': 'DB,Day7,pre-dose,n=23,12,12,12,12', 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '0.90', 'groupId': 'OG002'}, {'value': '1.9', 'spread': '1.00', 'groupId': 'OG003'}, {'value': '2.5', 'spread': '1.09', 'groupId': 'OG004'}]}]}, {'title': 'DB,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '1.13', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.16', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '0.85', 'groupId': 'OG003'}, {'value': '2.3', 'spread': '0.87', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine,Day1,pre-dose,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '90.7', 'spread': '9.73', 'groupId': 'OG000'}, {'value': '89.2', 'spread': '7.91', 'groupId': 'OG001'}, {'value': '85.8', 'spread': '10.38', 'groupId': 'OG002'}, {'value': '89.3', 'spread': '11.83', 'groupId': 'OG003'}, {'value': '86.5', 'spread': '9.89', 'groupId': 'OG004'}]}]}, {'title': 'Creatinine,Day14,pre-challenge,n=24,12,12,12,12', 'categories': [{'measurements': [{'value': '87.3', 'spread': '9.46', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '13.91', 'groupId': 'OG001'}, {'value': '84.3', 'spread': '13.47', 'groupId': 'OG002'}, {'value': '89.6', 'spread': '11.91', 'groupId': 'OG003'}, {'value': '86.8', 'spread': '10.06', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Total bilirubin and direct bilirubin were also assessed on Day 7 (pre-dose).', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Calcium,Day1,pre-dose', 'categories': [{'measurements': [{'value': '2.354', 'spread': '0.0618', 'groupId': 'OG000'}, {'value': '2.377', 'spread': '0.0873', 'groupId': 'OG001'}, {'value': '2.338', 'spread': '0.0591', 'groupId': 'OG002'}, {'value': '2.358', 'spread': '0.0618', 'groupId': 'OG003'}, {'value': '2.364', 'spread': '0.0710', 'groupId': 'OG004'}]}]}, {'title': 'Calcium,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '2.355', 'spread': '0.0896', 'groupId': 'OG000'}, {'value': '2.343', 'spread': '0.0568', 'groupId': 'OG001'}, {'value': '2.327', 'spread': '0.0627', 'groupId': 'OG002'}, {'value': '2.324', 'spread': '0.0562', 'groupId': 'OG003'}, {'value': '2.334', 'spread': '0.0566', 'groupId': 'OG004'}]}]}, {'title': 'Chloride,Day1,pre-dose', 'categories': [{'measurements': [{'value': '103.8', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '103.7', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '103.8', 'spread': '2.59', 'groupId': 'OG002'}, {'value': '104.0', 'spread': '1.21', 'groupId': 'OG003'}, {'value': '103.8', 'spread': '2.05', 'groupId': 'OG004'}]}]}, {'title': 'Chloride,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '104.7', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '104.5', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '104.6', 'spread': '1.73', 'groupId': 'OG002'}, {'value': '104.9', 'spread': '2.39', 'groupId': 'OG003'}, {'value': '104.4', 'spread': '1.62', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,Day1,pre-dose', 'categories': [{'measurements': [{'value': '5.10', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '5.04', 'spread': '0.425', 'groupId': 'OG001'}, {'value': '5.51', 'spread': '0.950', 'groupId': 'OG002'}, {'value': '4.87', 'spread': '0.375', 'groupId': 'OG003'}, {'value': '5.15', 'spread': '0.768', 'groupId': 'OG004'}]}]}, {'title': 'Glucose,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '5.18', 'spread': '0.832', 'groupId': 'OG000'}, {'value': '5.09', 'spread': '0.429', 'groupId': 'OG001'}, {'value': '5.23', 'spread': '1.052', 'groupId': 'OG002'}, {'value': '4.98', 'spread': '0.283', 'groupId': 'OG003'}, {'value': '5.32', 'spread': '0.949', 'groupId': 'OG004'}]}]}, {'title': 'Potassium,Day1,pre-dose', 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.304', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '0.224', 'groupId': 'OG001'}, {'value': '4.28', 'spread': '0.205', 'groupId': 'OG002'}, {'value': '4.32', 'spread': '0.279', 'groupId': 'OG003'}, {'value': '4.39', 'spread': '0.250', 'groupId': 'OG004'}]}]}, {'title': 'Potassium,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '4.35', 'spread': '0.320', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.257', 'groupId': 'OG001'}, {'value': '4.20', 'spread': '0.338', 'groupId': 'OG002'}, {'value': '4.36', 'spread': '0.239', 'groupId': 'OG003'}, {'value': '4.31', 'spread': '0.375', 'groupId': 'OG004'}]}]}, {'title': 'Sodium,Day1,pre-dose', 'categories': [{'measurements': [{'value': '139.8', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '139.2', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '139.1', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '139.7', 'spread': '1.83', 'groupId': 'OG003'}, {'value': '139.4', 'spread': '1.83', 'groupId': 'OG004'}]}]}, {'title': 'Sodium,Day14,pre-challenge', 'categories': [{'measurements': [{'value': '140.2', 'spread': '1.93', 'groupId': 'OG000'}, {'value': '139.3', 'spread': '2.19', 'groupId': 'OG001'}, {'value': '140.4', 'spread': '1.24', 'groupId': 'OG002'}, {'value': '139.6', 'spread': '1.51', 'groupId': 'OG003'}, {'value': '140.3', 'spread': '2.14', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.53'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '1.51'}, {'value': '0.33', 'groupId': 'OG002', 'lowerLimit': '0.18', 'upperLimit': '1.86'}, {'value': '0.66', 'groupId': 'OG003', 'lowerLimit': '0.38', 'upperLimit': '3.20'}, {'value': '0.95', 'groupId': 'OG004', 'lowerLimit': '0.52', 'upperLimit': '5.56'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-1.30', 'ciUpperLimit': '0.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.482', 'estimateComment': 'Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\\[2\\] = 1).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-0.73', 'ciUpperLimit': '1.28', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.495', 'estimateComment': 'Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\\[2\\] = 1).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '0.36', 'ciUpperLimit': '2.19', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.450', 'estimateComment': 'Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\\[2\\] = 1).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.79', 'ciLowerLimit': '0.84', 'ciUpperLimit': '2.75', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.469', 'estimateComment': 'Doubling dose differences, that is a treatment doubling dose difference of 1 indicates that the concentration of methacholine required to cause a 20% fall in FEV1 in one treatment is twice that in the other (log2\\[2\\] = 1).', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Methacholine challenge PC20 data the concentration of methacholine to cause \\>= 20% decrease (that is change \\<= -20%) in FEV1 compared with saline \\[Baseline\\]) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The PC20 was obtained by linear interpolation (on the log 2 concentration scale) between the lowest concentration of methacholine that caused at least 20% decrease from Baseline and the preceding concentration. The adjusted mean is presented as LSM.', 'unitOfMeasure': 'milligrams per milliliter', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'title': 'Eosinophils,n=17,6,6,4,10', 'categories': [{'measurements': [{'value': '0.024', 'spread': '1175.3', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '1038.7', 'groupId': 'OG001'}, {'value': '0.015', 'spread': '309.4', 'groupId': 'OG002'}, {'value': '0.007', 'spread': '464.2', 'groupId': 'OG003'}, {'value': '0.008', 'spread': '222.0', 'groupId': 'OG004'}]}]}, {'title': 'Neutrophils,n=17,6,7,4,10', 'categories': [{'measurements': [{'value': '0.064', 'spread': '1115.2', 'groupId': 'OG000'}, {'value': '0.086', 'spread': '3070.0', 'groupId': 'OG001'}, {'value': '0.069', 'spread': '228.3', 'groupId': 'OG002'}, {'value': '0.134', 'spread': '555.9', 'groupId': 'OG003'}, {'value': '0.053', 'spread': '280.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.', 'unitOfMeasure': '10^4 cells per milliliter of sputum', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '260.246', 'spread': '93.0', 'groupId': 'OG000'}, {'value': '330.822', 'spread': '165.6', 'groupId': 'OG001'}, {'value': '205.906', 'spread': '73.5', 'groupId': 'OG002'}, {'value': '287.877', 'spread': '85.3', 'groupId': 'OG003'}, {'value': '251.286', 'spread': '131.0', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.', 'unitOfMeasure': 'Picograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '863.936', 'spread': '162.7', 'groupId': 'OG000'}, {'value': '1252.473', 'spread': '57.9', 'groupId': 'OG001'}, {'value': '470.412', 'spread': '64.2', 'groupId': 'OG002'}, {'value': '408.389', 'spread': '127.2', 'groupId': 'OG003'}, {'value': '820.154', 'spread': '202.6', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '232.218', 'spread': '54.8', 'groupId': 'OG000'}, {'value': '264.893', 'spread': '40.6', 'groupId': 'OG001'}, {'value': '193.891', 'spread': '38.5', 'groupId': 'OG002'}, {'value': '263.454', 'spread': '167.9', 'groupId': 'OG003'}, {'value': '342.683', 'spread': '122.8', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.', 'unitOfMeasure': 'Micrograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. All participants were present at the time of assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants were assigned to take matching placebo of GW870086 or fluticasone propionate for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Placebo of GW870086 was provided as ROTADISK, while placebo of fluticasone propionate as MDPI. Placebo of GW870086 was administered via DISKHALER, while placebo of fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG001', 'title': 'GW870086 0.25 mg OD', 'description': 'Participants were assigned to take GW870086 0.25 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was a at least 14 days of washout from Day 13 dose.'}, {'id': 'OG002', 'title': 'GW870086 1 mg OD', 'description': 'Participants were assigned to take GW870086 1 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG003', 'title': 'GW870086 3 mg OD', 'description': 'Participants were assigned to take GW870086 3 mg OD for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. The formulation was prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK and was administered via DISKHALER. There was at least 14 days of washout from Day 13 dose.'}, {'id': 'OG004', 'title': 'Fluticasone Propionate 0.25 mg BID', 'description': 'Participants were assigned to take fluticasone propionate 0.25 mg BID for 13 days in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. Fluticasone propionate was provided as MDPI and administered via DISKUS inhaler. There was at least 14 days of washout from Day 13 dose.'}], 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study. The outcome is not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'All subject population. A GSK file note, dated 02 April 2009, was used to document that mRNA would no longer be collected from the sputum samples. This was due to the fact that a suitable laboratory could not be identified to carry out the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall Study', 'description': 'Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 milligram (mg), 1 mg, 3 mg once daily (OD), active control (fluticasone propionate 0.25 mg bi-daily \\[BID\\]) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as multi-dose powder inhaler (MDPI). GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Total 24 participants were enrolled from February-2009 to November-2009. ROTADISK™, DISKHALER™ and DISKUS™ were registered trademark product of GlaxoSmithKline.', 'preAssignmentDetails': 'Participants with pre-bronchodilator forced expiratory volume in 1 second (FEV1) \\>65% predicted at Screening, positive wheal and flare reaction (\\>=3 millimeter) on skin prick testing, early asthmatic response (EAR) and late asthmatic response (LAR) had to include a fall in FEV1 of \\>=20%, \\>=15%, respectively from the post saline value were included.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study', 'description': 'Participants were assigned to take 3 out of the 5 possible treatments for 13 days in a double-blind double dummy design: GW870086 0.25 mg, 1 mg, 3 mg OD, active control (fluticasone propionate 0.25mg BID) or placebo in accordance with the randomization schedule in each treatment period. All participants received matching placebo during one of the 3 treatment periods. All formulations were prepared in lactose inhalation blend and administered through oral inhalation. GW870086 was provided as ROTADISK, while fluticasone propionate as MDPI. GW870086 was administered via DISKHALER, while fluticasone propionate via DISKUS inhaler. There was a at least 14 days of washout from Day 13 dose.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '11.25', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2009-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2009-03-05', 'resultsFirstSubmitDate': '2017-04-20', 'studyFirstSubmitQcDate': '2009-03-05', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-11', 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late Asthmatic Response (LAR): Minimum FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period', 'timeFrame': '4-10 hours after allergen challenge on Day 13 of each treatment period', 'description': 'Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 4-10 hours post allergen challenge was minimum value of all the post-saline time points between 4 to 10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours). The adjusted mean is presented as least square mean (LSM).'}], 'secondaryOutcomes': [{'measure': 'LAR: Weighted Mean FEV1 Between 4-10 Hours After Allergen Challenge on Day 13 of Each Treatment Period.', 'timeFrame': '4-10 hours after allergen challenge on Day 13 of each treatment period', 'description': 'Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Weighted mean LAR was calculated for FEV1 over 4-10 hours (4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours) post allergen challenge using the linear trapezoidal rule. To calculate weighted mean LAR, all FEV1 values recorded after the administration of rescue medication have been set to the last recorded FEV1 value prior to the administration of rescue medication. The adjusted mean is presented as Least square mean (LSM).'}, {'measure': 'EAR: Minimum FEV1 and Weighted Mean FEV1 Between 0-2 Hours After Allergen Challenge on Day 13 of Each Treatment Period.', 'timeFrame': '0-2 hours after challenge on Day 13 of each treatment period (approximately 17 weeks)', 'description': 'Analyzed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. Minimum FEV1 over 0-2 hrs post-allergen challenge (minimum EAR) was the minimum value of all the post-(bolus) allergen challenge. Weighted mean EAR was calculated for FEV1 over 0-2 hours post allergen challenge using the linear trapezoidal rule. It was measured up to and including 2 hours (5, 10, 15, 20, 30, 45 minutes and 1, 1.5 and 2 hours). The adjusted mean is presented as LSM.'}, {'measure': 'Concentration of Exhaled NO Pre-dose on Day 13 of Each Treatment Period', 'timeFrame': 'Day 13 of each treatment period (approximately 17 weeks)', 'description': 'Exhaled NO concentration data collected on Day 13 (pre-dose) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The adjusted mean is presented.'}, {'measure': 'Concentration of Exhaled NO Post-dose on Day 13 of Each Treatment Period', 'timeFrame': 'Day 13 of each treatment period (approximately 17 weeks)', 'description': 'Exhaled NO concentration data collected on Day 13 (2 and 12 hours post-dose) and was measured 3 times at each time point. The outcome was not assessed and data not reported.'}, {'measure': 'Number of Participants With Adverse Events (AE), Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)', 'timeFrame': 'Up to 17 weeks', 'description': 'An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.'}, {'measure': 'Mean Values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Participants were required to rest in the supine position for at least 10 minutes before each reading. SBP and DBP was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge \\[pre saline\\]) and Day 14 (pre and 1 hour post methacholine challenge).'}, {'measure': 'Mean Values for Heart Rate', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Participants were required to rest in the supine position for at least 10 minutes before each reading. Heart rate was measured on Day 1 (pre-dose and 1 hour post dose), Day 7 (any time post morning dose), Day 13 (pre allergen challenge) and Day 14 (pre and 1 hour post methacholine challenge).'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Single 12-lead ECGs were obtained at each time point during the study using an ECG machine that automatically calculated the heart rate and measures PR, QRS, QT, and QTc intervals. It was measured on Day 1 (pre-dose and 1 hour post dose) and Day 14 (pre and 1 hour post methacholine challenge). Participants with normal (Nr), abnormal not clinically significant (ANCS) and abnormal clinically significant (ACS) ECG was presented.'}, {'measure': 'Change From Baseline in FEV1-allergen Challenge at Each Time Point', 'timeFrame': 'Up to Day 13 of each treatment period (approximately 17 weeks)', 'description': 'A mixed model analysis was performed separately for each planned time point during the allergen challenge on Day 13, from 5 minutes to 10 hour, including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. Absolute change from saline Baseline was calculated for each participant and time point as value equal to highest challenge value minus highest saline value. FEV1 was measured at 5, 10, 15, 20, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5 and 10 hours. The adjusted mean is presented as LSM.'}, {'measure': 'Mean Laboratory Values for Platelet, White Blood Cells (WBC), Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Change From Baseline in FEV1-non Allergen Challenge', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Non-allergen challenge FEV1 data was measured on Day 1, 7, 13 and 14. The FEV1 assessments on Day 1 was taken at pre-dose and those on Day 7 was taken post-dose. On Day 13, the pre-allergen challenge FEV1 values was used and on Day 14 the pre-methacholine challenge FEV1 values was used. Absolute change in FEV1 on Day 7, 13 and 14 from pre-dose FEV1 was analyzed separately using a mixed-effects ANOVA model. Period-level Baseline was defined as the difference between the Day 1 pre-dose value and participant-level Baseline for each period, each participant. The change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value. Post-randomization values refer to assessments performed post dose and after the Baseline assessment. The adjusted mean is presented as LSM.'}, {'measure': 'Mean Laboratory Values for Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Mean Laboratory Values for Hematocrit', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Mean Laboratory Values for Mean Corpuscle Hemoglobin (MCH)', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Mean Laboratory Values for Mean Corpuscle Volume (MCV)', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Mean Laboratory Values for Reticulocytes', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of hematology was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Mean Laboratory Values for Albumin and Total Protein', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Mean Laboratory Values for Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Liver safety parameters (ALT and AST) were also assessed on Day 7 (pre-dose).'}, {'measure': 'Mean Laboratory Values for Total Bilirubin, Direct Bilirubin and Creatinine', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge). Total bilirubin and direct bilirubin were also assessed on Day 7 (pre-dose).'}, {'measure': 'Mean Laboratory Values for Calcium, Glucose, Potassium, Chloride and Sodium', 'timeFrame': 'Up to Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Blood samples for assessment of clinical chemistry was collected on Day 1 (pre-dose) and Day 14 (pre methacholine challenge).'}, {'measure': 'Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 14 of Each Treatment Period.', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Methacholine challenge PC20 data the concentration of methacholine to cause \\>= 20% decrease (that is change \\<= -20%) in FEV1 compared with saline \\[Baseline\\]) was log transformed and analysed using a mixed effects model including covariates for participant level Baseline FEV1 and period level Baseline FEV1. Participant level Baseline was defined as the mean of Day 1 pre-dose values across periods for each participant and period level Baseline as the difference between the Day 1 pre-dose value and participant level Baseline for each period. The PC20 was obtained by linear interpolation (on the log 2 concentration scale) between the lowest concentration of methacholine that caused at least 20% decrease from Baseline and the preceding concentration. The adjusted mean is presented as LSM.'}, {'measure': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-cell Counts of Eosinophils and Neutrophils', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.'}, {'measure': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-myeloperoxidase (MPO)', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.'}, {'measure': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-interleukin-8 (IL-8)', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.'}, {'measure': 'Assessment of Established Markers of Anti-inflammatory Activity in Sputum on Day 14-total Protein', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study.'}, {'measure': 'Number of Participants With Established Markers of Anti-inflammatory Activity in Sputum on Day 14-messenger Ribonucleic Acid (mRNA)', 'timeFrame': 'Day 14 of each treatment period (approximately 17 weeks)', 'description': 'Sputum induction was performed during each treatment period for biomarker analysis 1-2 hour after the methacholine challenge on Day 14. Sputum samples were collected from a minimum of 10 participants in the study. The outcome is not assessed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['asthma', 'late phase response', 'allergen', 'challenge', 'GW870086X'], 'conditions': ['Asthma']}, 'referencesModule': {'availIpds': [{'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '110762', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'references': [{'type': 'BACKGROUND', 'citation': 'Bareille P, Allen A, Hardes K, Donald A. Effect of repeat inhaled doses of GW870086 on the allergen-induced early and late asthmatic response in subjects with mild asthma. Curr Drug Ther. 2013;8(2)'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'The study will measure the early and late asthamtic response using an allergen challenge. This study will evaluate the safety and patients tolerance to repeat inhaled doses of GW870086X using a number of clinical and biological markers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male subjects between 18 and 65 years of age inclusive.\n* Male subjects must agree to use one of the contraception methods listed in Section 8. This criterion must be followed from the time of the first dose of study medication until 90-95 hours post-last dose.\n* BMI within the range 19.0 - 29.0 kg/m2 (inclusive).\n* Liver function tests (bilirubin, AST, ALT) within normal laboratory parameters at screening.\n* Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.\n* Pre-bronchodilator FEV1 \\>65% of predicted at screening.\n* No history of smoking within 6 months of the start of the study, and with a total pack year history of \\<= 10 pack years\n* Demonstration of a positive wheal and flare reaction (\\>= 3 mm relative to negative control) to at least one allergen from a battery of allergens (including but not limited to house dust mite, grass pollen, cat dander, hazel, horse and birch) on skin prick testing at screening, or within 12 months of study start.\n* Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of \\>= 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of \\>= 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen.\n* Reproducible allergen challenge at screening (confirmation of the dose ascending allergen challenge by a bolus allergen challenge at least 14 days later).\n* Sensitivity to methacholine with a provocative concentration of methacholine resulting in a 20% fall in FEV1 (PC20 methacholine) of \\<8 mg/mL at screening.\n* Subjects who are able to produce acceptable induced sputum samples (as defined in the Study Procedures Manual).\n* Be able to give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n* Single QTcB or QTcF \\< 450 msec; or QTc \\< 480 msec in subjects with Bundle Branch Block.\n\nExclusion Criteria:\n\n* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, bronchiectasis or pulmonary fibrosis).\n* Clinically significant abnormalities in safety laboratory analysis at screening.\n* Subject has known history of hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP \\>140mmHg or diastolic BP \\> 90mmHg.\n* Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.\n* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.\n* Administration of oral, injectable or dermal steroids within 4 weeks or intranasal and/or inhaled steroids within 2 week of the screening visit.\n* The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.\n* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.\n* A positive test for HIV antibody.\n* History of regular alcohol consumption within 6 months of the study defined as:\n\nan average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.\n\n* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.\n* Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up.\n* Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-agonists within 1 week prior to screening and is unable to abstain from them throughout the study.\n* Unable to abstain from other medications including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma (not including steroids), anti-rhinitis or hay fever medication, other than short acting inhaled beta-agonists and paracetamol (up to 4 g per day) for the treatment of minor ailments eg headache from 7 days before screening until the follow-up visit.\n* Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazol from screening and throughout the study.\n* Unable to use the DISKHALER and/or DISKUS device correctly.\n* History of being unable to tolerate or complete methacholine or allergen challenge tests.\n* If, after 2 concurrent administrations of saline during the allergen challenge at screening the subjects still have a fall in FEV1 of greater than 10%.\n* Subject is undergoing allergen desensitisation therapy.\n* History of sensitivity to any of the study medications (including lactose), or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.\n* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.\n* Unwillingness or inability to follow the procedures outlined in the protocol.\n* Subjects who are kept due to regulatory or juridical order in an institution.\n* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.\n* Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication."}, 'identificationModule': {'nctId': 'NCT00857857', 'briefTitle': 'A Study to Evaluate the Effect of GW870086X on Allergen Challenge in Mild Asthmatics', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomised, Placebo-controlled, Incomplete Block, Three-way Cross-over Study to Evaluate the Effect of Treatment With Repeat Inhaled Doses of GW870086X on the Allergen-induced Early and Late Asthmatic Response in Subjects With Mild Asthma', 'orgStudyIdInfo': {'id': '110762'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '13 day repeat dose', 'interventionNames': ['Drug: GW870086X', 'Drug: FP', 'Drug: Placebo']}], 'interventions': [{'name': 'GW870086X', 'type': 'DRUG', 'description': 'Investigational product', 'armGroupLabels': ['13 day repeat dose']}, {'name': 'FP', 'type': 'DRUG', 'description': 'Positive control', 'armGroupLabels': ['13 day repeat dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo control', 'armGroupLabels': ['13 day repeat dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65187', 'city': 'Wiesbaden', 'state': 'Hesse', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '22927', 'city': 'Großhansdorf', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}