Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-07 @ 3:47 PM
Study NCT ID:
NCT01627327
Status:
COMPLETED
Last Update Posted:
2017-11-09
First Post:
2012-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523187', 'term': 'fluticasone furoate'}, {'id': 'C550468', 'term': 'vilanterol'}, {'id': 'D000069447', 'term': 'Tiotropium Bromide'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, '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': 'On-Treatment serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 13 weeks).', 'description': 'An on-treatment AE or SAE is defined as an AE with an onset on or after the start date of study medication, but not later than one day after the last date of study medication. SAEs and AEs were collected in members of the ITT Population, comprised of all participants randomized to treatment, who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'FF/VI 100/25 µg OD', 'description': 'Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.', 'otherNumAtRisk': 310, 'otherNumAffected': 31, 'seriousNumAtRisk': 310, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'TIO 18 µg OD', 'description': 'Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.', 'otherNumAtRisk': 313, 'otherNumAffected': 32, 'seriousNumAtRisk': 313, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Graft infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood pressure fluctuation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Leriche syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 310, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FF/VI 100/25 µg OD', 'description': 'Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.'}, {'id': 'OG001', 'title': 'TIO 18 µg OD', 'description': 'Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.117', 'spread': '0.0130', 'groupId': 'OG000'}, {'value': '0.095', 'spread': '0.0138', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.201', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.022', 'ciLowerLimit': '-0.012', 'ciUpperLimit': '0.055', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 84', 'description': 'Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) Population: all participants who were randomized and received at least one dose of study medication. Only participants with data available at the indicated time point were assessed.'}, {'type': 'SECONDARY', 'title': 'Time to Onset on Treatment Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FF/VI 100/25 µg OD', 'description': 'Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.'}, {'id': 'OG001', 'title': 'TIO 18 µg OD', 'description': 'Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '240'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '240'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Day 1', 'description': 'Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with data available at the indicated time point were assessed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Trough FEV1 at Treatment Day 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FF/VI 100/25 µg OD', 'description': 'Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.'}, {'id': 'OG001', 'title': 'TIO 18 µg OD', 'description': 'Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.098', 'spread': '0.0133', 'groupId': 'OG000'}, {'value': '0.093', 'spread': '0.0140', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 84', 'description': 'Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population. Only participants with data available at the indicated time point were assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FF/VI 100/25 µg OD', 'description': 'Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.'}, {'id': 'FG001', 'title': 'TIO 18 µg OD', 'description': 'Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '313'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '291'}, {'groupId': 'FG001', 'numSubjects': '274'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Lack of Efficacy-No Sub-Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy-Sub-Reason Exacerbation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Eligible participants (par.) completed a 2-week Run-in Period (RIP) to obtain baseline assessments of rescue use, COPD symptom scores and disease stability. Par. were then randomized to a 12-week Treatment Period. A total of 890 par. were screened, of whom 623 were randomized and received at least one dose of study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '623', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'FF/VI 100/25 µg OD', 'description': 'Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.'}, {'id': 'BG001', 'title': 'TIO 18 µg OD', 'description': 'Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '8.09', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '7.98', 'groupId': 'BG001'}, {'value': '62.6', 'spread': '8.03', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '209', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'African American/African Heritage', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Asian - East Asian Heritage', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White - White/Caucasian/European Heritage', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 623}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'dispFirstSubmitDate': '2013-06-20', 'completionDateStruct': {'date': '2012-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2012-06-21', 'dispFirstSubmitQcDate': '2013-06-20', 'resultsFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2012-06-21', 'dispFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-29', 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline Trough in 24-hour Weighted Mean FEV1 on Treatment Day 84', 'timeFrame': 'Baseline and Day 84', 'description': 'Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. The weighted mean was calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, 30 minutes and 1, 2, 4, 6, 8, 12, 13, 14, 16, 20, and 24 hours on Treatment Day 84. Baseline trough FEV1 was the mean of the two assessments made 30 and 5 minutes pre-dose on Treatment Day 1. Change from Baseline (BL) was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an analysis of covariance (ANCOVA) model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.'}], 'secondaryOutcomes': [{'measure': 'Time to Onset on Treatment Day 1', 'timeFrame': 'Baseline and Day 1', 'description': 'Time to onset on Treatment Day 1 is defined as the time to an increase of 100 milliliters (mL) from Baseline in FEV1. Time of onset was calculated over 0 to 4 hours (5 minutes (min), 15 min, 30 min, 60 min, 120 min, and 240 min) post-dose. Time to onset was analyzed using a log-rank test, stratified by exacerbation history and reversibility stratum.'}, {'measure': 'Change From Baseline in Trough FEV1 at Treatment Day 84', 'timeFrame': 'Baseline and Day 84', 'description': 'Pulmonary function was measured by FEV1. Trough FEV1 was defined as the 24-hour FEV1 assessment, which was obtained on Day 84. Baseline is defined as the mean of the two assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1.Change from Baseline was calculated as the average of the Day 84 values minus the Baseline value. Analysis was performed using an ANCOVA model with covariates of BL FEV1, exacerbation history and reversibility stratum, smoking status at screening, country, and treatment group.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular event', 'Cardiovascular disease'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'availIpds': [{'id': '115805', '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': '115805', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115805', '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': '115805', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '115805', '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': '115805', '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': '115805', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], '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 purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease', 'detailedDescription': 'This is a randomized, double-blind, double-dummy, multi-center, parallel-group study. Subjects who meet the eligibility criteria at Screening and at the end of a 2-week Run-In Period will enter a 12-week Treatment Period. There will be a 7-day Follow-up Period after the Treatment Period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed and dated written informed consent\n* Male or females ≥ 40 years of age\n* Females must be post-menopausal or using a highly effective method for avoidance of pregnancy\n* Established clinical history of COPD by ATS/ERS definition\n* Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)\n* Former or current smoker ≥10 pack years\n* A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:\n* Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)\n* Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)\n* Previous stroke\n* Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)\n* Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary)\n\nOR\n\n* Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):\n* Current diagnosis of hypertension\n* Current diagnosis of hypercholesterolemia\n* Diabetes mellitus treated with pharmacotherapy\n\nExclusion Criteria:\n\n* Current diagnosis of asthma\n* Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases\n* Lung volume reduction surgery within previous 12 months\n* Clinically significant abnormalities not due to COPD by chest X-ray or CT scan\n* Hospitalized for poorly controlled COPD within 12 weeks of Screening\n* Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician\n* Lower respiratory infection requiring antibiotics 6 weeks prior to Screening\n* A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period\n* An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization\n* An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization\n* An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)\n* Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at \\>60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction \\<30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities\n* Carcinoma not in complete remission for at least 5 years\n* History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded\n* Known/suspected history of alcohol or drug abuse in the last 2 years\n* Women who are pregnant or lactating or plan to become pregnant\n* Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit\n* Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)\n* Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy \\>12 hours a day\n* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study\n* Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments\n* Non-compliance or inability to comply with study procedures or scheduled visits\n* History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study\n* Affiliation with investigator site\n* Women who are pregnant or lactating or are planning on becoming pregnant during the study"}, 'identificationModule': {'nctId': 'NCT01627327', 'briefTitle': 'Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate 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