Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT01061333
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2010-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Early Airway Response to Allergen in Asthmatics (MK-0000-176)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Kingdom']}, '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': 'D017835', 'term': 'Nedocromil'}, {'id': 'C093875', 'term': 'montelukast'}], 'ancestors': [{'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'For multicenter studies, subsequent to the multicenter publication, an investigator and colleagues may publish their data independently. Limitations of single site observations should always be described in such a manuscript. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 60 days prior to submission. Any information identified by the SPONSOR as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler', 'otherNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge', 'otherNumAtRisk': 15, 'otherNumAffected': 3, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.66', 'spread': '10.72', 'groupId': 'OG000'}, {'value': '-8.44', 'spread': '6.15', 'groupId': 'OG001'}, {'value': '-9.15', 'spread': '6.96', 'groupId': 'OG002'}, {'value': '-16.17', 'spread': '11.01', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in LS mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '16.22', 'ciLowerLimit': '10.74', 'ciUpperLimit': '21.69', 'pValueComment': 'p-value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '15.51', 'ciLowerLimit': '10.00', 'ciUpperLimit': '21.02', 'pValueComment': 'p-value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0432', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Difference in LS Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '8.49', 'ciLowerLimit': '1.78', 'ciUpperLimit': '15.20', 'pValueComment': 'p-value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Pre-allergen challenge and 20 minutes after allergen challenge', 'description': 'Maximal percent drop in FEV1 at 20 minutes post allergen challenge', 'unitOfMeasure': 'Percentage drop in FEV1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, Montelukast placebo tablet, Mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.17', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '0.35', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.27', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.54', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.0100', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.41', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.72', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.0860', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.30', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.67', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-allergen challenge and 5 minutes post allergen challenge', 'description': 'Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge', 'unitOfMeasure': 'Fold change over baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Plasma 9P at 20 Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '1.22', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.72', 'spread': '0.21', 'groupId': 'OG002'}, {'value': '1.06', 'spread': '0.40', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.59', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.70', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.59', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.70', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.2679', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.87', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.08', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-allergen challenge and 20 minutes post allergen challenge', 'description': 'Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge', 'unitOfMeasure': 'Fold change over baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Allergen-induced Changes in Urinary 9P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '1.54', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '2.54', 'groupId': 'OG001'}, {'value': '1.45', 'spread': '4.22', 'groupId': 'OG002'}, {'value': '1.40', 'spread': '2.24', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7622', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.90', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.59', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.8468', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.94', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.65', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated on log scale', 'testedNonInferiority': False}, {'pValue': '0.6140', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.91', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.26', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 2 hours post allergen challenge', 'description': 'Fold change over baseline in Urinary 9P at 2 hours post allergen challenge', 'unitOfMeasure': 'Fold change over baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with baseline values were analyzed'}, {'type': 'SECONDARY', 'title': 'Allergen-induced Changes in Urinary Leukotriene (LT) E4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '1.77', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '1.52', 'groupId': 'OG002'}, {'value': '1.62', 'spread': '1.35', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.67', 'ciLowerLimit': '0.57', 'ciUpperLimit': '0.80', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.0291', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.79', 'ciLowerLimit': '0.67', 'ciUpperLimit': '0.94', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.3738', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. Mean Ratio of fold over baseline', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.92', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.08', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 2 hours post allergen challenge', 'description': 'Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge', 'unitOfMeasure': 'Fold change over baseline', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants with baseline values were analyzed'}, {'type': 'SECONDARY', 'title': 'Allergen-induced Concentrations of Sputum LTC4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '13.63', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '14.02', 'spread': '12.53', 'groupId': 'OG001'}, {'value': '13.76', 'spread': '5.45', 'groupId': 'OG002'}, {'value': '12.14', 'spread': '6.94', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.7501', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.20', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.9410', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.01', 'ciLowerLimit': '0.81', 'ciUpperLimit': '1.25', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.1165', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.89', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.01', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 hours post allergen challenge', 'description': 'Concentrations of LTC4 in sputum at 2 hours post-allergen challenge', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.'}, {'type': 'SECONDARY', 'title': 'Allergen-induced Concentrations of Sputum LTD4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '17.48', 'spread': '15.20', 'groupId': 'OG000'}, {'value': '18.04', 'spread': '31.13', 'groupId': 'OG001'}, {'value': '18.52', 'spread': '9.22', 'groupId': 'OG002'}, {'value': '17.37', 'spread': '36.91', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.8616', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.41', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.7512', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.06', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.45', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.9723', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.37', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 hours post allergen challenge', 'description': 'Concentrations of LTD4 in sputum at 2 hours post-allergen challenge', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.'}, {'type': 'SECONDARY', 'title': 'Allergen-induced Concentrations of Sputum LTE4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler'}, {'id': 'OG001', 'title': 'Nedocromil', 'description': 'Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge'}, {'id': 'OG002', 'title': 'Montelukast', 'description': 'Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge'}, {'id': 'OG003', 'title': 'Mometasone', 'description': 'Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge'}], 'classes': [{'categories': [{'measurements': [{'value': '115.5', 'spread': '129.0', 'groupId': 'OG000'}, {'value': '149.8', 'spread': '178.7', 'groupId': 'OG001'}, {'value': '181.3', 'spread': '227.6', 'groupId': 'OG002'}, {'value': '140.3', 'spread': '215.8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.1983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.30', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.82', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.0872', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.57', 'ciLowerLimit': '1.02', 'ciUpperLimit': '2.42', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}, {'pValue': '0.2499', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Geom. mean of fold change over Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.22', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.62', 'pValueComment': 'p-Value not adjusted for simultaneous multiple comparisons', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'concentrations evaluated at log scale', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '2 hours post allergen challenge', 'description': 'Concentrations of LTE4 in sputum at 2 hours post-allergen challenge', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pre-imputation status. Missing data points were excluded and values below the lower limit of quantification (LLOQ) were included in the analysis with an assigned value of assay LLOQ.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo-Montelukast-Nedocromil-Mometasone', 'description': 'Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.'}, {'id': 'FG001', 'title': 'Placebo-Nedocromil-Montelukast-Mometasone', 'description': 'Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.'}], 'periods': [{'title': 'Period 1: Placebo Run-in', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2: 20-day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3: Nedocromil-Montelukast X-over', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 4: 20-day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Discontinued by Study Team', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 5: Nedocromil-Montelukast X-over', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 6: 20-day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 7: Mometasone', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.94', 'spread': '7.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-03', 'studyFirstSubmitDate': '2010-02-01', 'resultsFirstSubmitDate': '2012-04-26', 'studyFirstSubmitQcDate': '2010-02-02', 'lastUpdatePostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-26', 'studyFirstPostDateStruct': {'date': '2010-02-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Pre-allergen challenge and 20 minutes after allergen challenge', 'description': 'Maximal percent drop in FEV1 at 20 minutes post allergen challenge'}, {'measure': 'Change in Plasma 9α-11β-PGF2 (9P) at 5 Minutes', 'timeFrame': 'Pre-allergen challenge and 5 minutes post allergen challenge', 'description': 'Fold change over baseline of plasma 9P at 5 minutes post-allergen challenge'}, {'measure': 'Change in Plasma 9P at 20 Minutes', 'timeFrame': 'Pre-allergen challenge and 20 minutes post allergen challenge', 'description': 'Fold change over baseline of plasma 9P at 20 minutes post-allergen challenge'}], 'secondaryOutcomes': [{'measure': 'Allergen-induced Changes in Urinary 9P', 'timeFrame': 'Baseline and 2 hours post allergen challenge', 'description': 'Fold change over baseline in Urinary 9P at 2 hours post allergen challenge'}, {'measure': 'Allergen-induced Changes in Urinary Leukotriene (LT) E4', 'timeFrame': 'Baseline and 2 hours post allergen challenge', 'description': 'Fold change over baseline in urinary LTE4 at 2 hours post-allergen challenge'}, {'measure': 'Allergen-induced Concentrations of Sputum LTC4', 'timeFrame': '2 hours post allergen challenge', 'description': 'Concentrations of LTC4 in sputum at 2 hours post-allergen challenge'}, {'measure': 'Allergen-induced Concentrations of Sputum LTD4', 'timeFrame': '2 hours post allergen challenge', 'description': 'Concentrations of LTD4 in sputum at 2 hours post-allergen challenge'}, {'measure': 'Allergen-induced Concentrations of Sputum LTE4', 'timeFrame': '2 hours post allergen challenge', 'description': 'Concentrations of LTE4 in sputum at 2 hours post-allergen challenge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': "This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of mild to moderate Asthma\n* In good general health (except for asthma)\n* Stable and free of respiratory infection\n* Nonsmoker\n* Females highly unlikely to conceive (surgically sterilized, postmenopausal, or agrees to use 2 acceptable methods of birth control)\n\nExclusion Criteria:\n\n* Nursing mother\n* Recent or ongoing upper or lower respiratory tract infection\n* Unable to refrain from or anticipates the use of any prescription and non-prescription drugs\n* Consumes excessive amounts of alcohol or caffeine\n* History of stroke, chronic seizures, or major neurological disorder\n* History of cancer\n* Received a vaccination within the past 3 weeks'}, 'identificationModule': {'nctId': 'NCT01061333', 'briefTitle': 'Early Airway Response to Allergen in Asthmatics (MK-0000-176)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics', 'orgStudyIdInfo': {'id': '0000-176'}, 'secondaryIdInfos': [{'id': '2010_507', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Montelukast', 'description': 'Montelukast', 'interventionNames': ['Drug: Comparator: Montelukast']}, {'type': 'EXPERIMENTAL', 'label': 'Nedocromil', 'description': 'Nedocromil', 'interventionNames': ['Drug: Nedocromil']}, {'type': 'EXPERIMENTAL', 'label': 'Mometasone', 'description': 'Mometasone', 'interventionNames': ['Drug: Comparator: Mometasone']}], 'interventions': [{'name': 'Nedocromil', 'type': 'DRUG', 'description': 'Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge', 'armGroupLabels': ['Nedocromil']}, {'name': 'Comparator: Montelukast', 'type': 'DRUG', 'otherNames': ['Singulair'], 'description': 'Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge', 'armGroupLabels': ['Montelukast']}, {'name': 'Comparator: Mometasone', 'type': 'DRUG', 'description': 'Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge', 'armGroupLabels': ['Mometasone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}