Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00383435
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2006-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'Costa Rica', 'Croatia', 'Denmark', 'Guatemala', 'Hungary', 'India', 'Mexico', 'Netherlands', 'Peru', 'Philippines', 'Poland', 'Russia', 'Serbia', 'Slovakia', 'Slovenia', 'South Africa', 'Thailand', 'Ukraine', 'United States', 'Uzbekistan', 'Venezuela']}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], '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': 'D000068656', 'term': 'Mometasone Furoate'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The investigator has the right to publish or publicly present results. The investigator agrees not to publish or publicly present any interim results without prior written consent of the sponsor. The investigator agrees to provide to the sponsor 45 days before submission for publication that report results of the study. The sponsor shall have the right to review \\& comment with respect to publications, abstracts, slides, \\& manuscripts \\& the right to review \\& comment on the data \\& presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Treatment period for adverse events was 52 weeks for MF/F MDI 400/10 mcg BID, MF/F MDI 200/10 mcg BID, MF MDI 400 mcg BID, and F MDI 10 mcg BID and 26 weeks for placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'MF/F MDI 200/10 MCG BID', 'otherNumAtRisk': 207, 'otherNumAffected': 8, 'seriousNumAtRisk': 207, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'MF/F MDI 400/10 MCG BID', 'otherNumAtRisk': 217, 'otherNumAffected': 10, 'seriousNumAtRisk': 217, 'seriousNumAffected': 29}, {'id': 'EG002', 'title': 'MF MDI 400 MCG BID', 'otherNumAtRisk': 210, 'otherNumAffected': 9, 'seriousNumAtRisk': 210, 'seriousNumAffected': 22}, {'id': 'EG003', 'title': 'F MDI 10 MCG BID', 'otherNumAtRisk': 209, 'otherNumAffected': 11, 'seriousNumAtRisk': 209, 'seriousNumAffected': 29}, {'id': 'EG004', 'title': 'PLACEBO', 'otherNumAtRisk': 212, 'otherNumAffected': 11, 'seriousNumAtRisk': 212, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 21, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 22, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'ACUTE MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANGINA PECTORIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'ANGINA UNSTABLE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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PULMONALE CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CORONARY ARTERY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'MYOCARDIAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PALPITATIONS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GOITRE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CATARACT NUCLEAR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'GLAUCOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, 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'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HERNIAL EVENTRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'OESOPHAGEAL FOOD IMPACTION', 'stats': [{'groupId': 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'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'CAROTID ENDARTERECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'INCISIONAL HERNIA REPAIR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'FEMORAL ARTERIAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'PERIPHERAL ARTERY ANEURYSM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'POOR PERIPHERAL CIRCULATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 207, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 210, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 209, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '207', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '207', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'OG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'OG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.186', 'spread': '0.418', 'groupId': 'OG000'}, {'value': '1.227', 'spread': '0.418', 'groupId': 'OG001'}, {'value': '1.255', 'spread': '0.418', 'groupId': 'OG002'}, {'value': '1.252', 'spread': '0.418', 'groupId': 'OG003'}, {'value': '1.227', 'spread': '0.418', 'groupId': 'OG004'}]}]}, {'title': 'Endpoint (Change from Baseline)', 'categories': [{'measurements': [{'value': '0.166', 'spread': '0.258', 'groupId': 'OG000'}, {'value': '0.126', 'spread': '0.258', 'groupId': 'OG001'}, {'value': '0.057', 'spread': '0.258', 'groupId': 'OG002'}, {'value': '0.077', 'spread': '0.258', 'groupId': 'OG003'}, {'value': '0.003', 'spread': '0.258', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.007', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Endpoint (13 weeks)', 'description': 'FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT) population'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '206', 'groupId': 'OG002'}, {'value': '208', 'groupId': 'OG003'}, {'value': '204', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'OG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'OG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.191', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '1.223', 'spread': '0.424', 'groupId': 'OG001'}, {'value': '1.258', 'spread': '0.424', 'groupId': 'OG002'}, {'value': '1.252', 'spread': '0.424', 'groupId': 'OG003'}, {'value': '1.230', 'spread': '0.424', 'groupId': 'OG004'}]}]}, {'title': 'Endpoint (Change from Baseline)', 'categories': [{'measurements': [{'value': '0.111', 'spread': '0.270', 'groupId': 'OG000'}, {'value': '0.058', 'spread': '0.270', 'groupId': 'OG001'}, {'value': '0.027', 'spread': '0.270', 'groupId': 'OG002'}, {'value': '0', 'spread': '0.270', 'groupId': 'OG003'}, {'value': '-0.017', 'spread': '0.270', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.029', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Endpoint (13 weeks)', 'description': 'Endpoint was the last post-baseline non-missing result through Week 13 carried\n\nforward.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '193', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}, {'value': '198', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'OG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'OG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '45.05', 'spread': '18.48', 'groupId': 'OG000'}, {'value': '45.89', 'spread': '18.48', 'groupId': 'OG001'}, {'value': '47.00', 'spread': '18.48', 'groupId': 'OG002'}, {'value': '44.87', 'spread': '18.48', 'groupId': 'OG003'}, {'value': '44.60', 'spread': '18.48', 'groupId': 'OG004'}]}]}, {'title': 'Endpoint (Change from Baseline)', 'categories': [{'measurements': [{'value': '-7.43', 'spread': '14.72', 'groupId': 'OG000'}, {'value': '-5.69', 'spread': '14.72', 'groupId': 'OG001'}, {'value': '-6.99', 'spread': '14.72', 'groupId': 'OG002'}, {'value': '-6.18', 'spread': '14.72', 'groupId': 'OG003'}, {'value': '-2.87', 'spread': '14.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.059', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Endpoint (26 weeks)', 'description': 'SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), \\& total score. Best health scores have a low numeric value. All component scores \\& total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}, {'value': '206', 'groupId': 'OG003'}, {'value': '205', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'OG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'OG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.345', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '0.345', 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.345', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '0.345', 'groupId': 'OG003'}, {'value': '0.31', 'spread': '0.345', 'groupId': 'OG004'}]}]}, {'title': 'Endpoint (Change from Baseline)', 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.11', 'spread': '0.27', 'groupId': 'OG002'}, {'value': '0.14', 'spread': '0.27', 'groupId': 'OG003'}, {'value': '0.06', 'spread': '0.27', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Endpoint (26 weeks)', 'description': 'Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.', 'unitOfMeasure': 'Proportion of symptom-free nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Partly Stable COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}, {'value': '212', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'OG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'OG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Endpoint (26 weeks)', 'description': 'Partly stable COPD was a composite measure that included the following COPD\n\noutcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or\n\ntreatment-related adverse event as determined by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mild, Moderate, or Severe COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}, {'value': '210', 'groupId': 'OG002'}, {'value': '209', 'groupId': 'OG003'}, {'value': '212', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'OG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'OG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'classes': [{'title': 'Mild', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Endpoint (26 weeks)', 'description': 'Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'FG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'FG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'FG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}], 'periods': [{'title': '26-Week Double-Blind Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '207'}, {'groupId': 'FG002', 'numSubjects': '210'}, {'groupId': 'FG003', 'numSubjects': '209'}, {'groupId': 'FG004', 'numSubjects': '212'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '176'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '164'}, {'groupId': 'FG003', 'numSubjects': '172'}, {'groupId': 'FG004', 'numSubjects': '159'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '46'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Participant withdrawal unrelated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '17'}]}, {'type': 'Participant withdrawal related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Did not meet protocol eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}, {'title': '26-Week Treatment Safety Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '131'}, {'groupId': 'FG001', 'numSubjects': '130'}, {'groupId': 'FG002', 'numSubjects': '124'}, {'groupId': 'FG003', 'numSubjects': '131'}, {'groupId': 'FG004', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '108'}, {'groupId': 'FG003', 'numSubjects': '116'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Participant withdrawal unrelated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant withdrawal related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Non-compliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Did not meet protocol eligibility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'At Week 26, all participants randomized to placebo were to be discontinued, while 75% of participants randomized to an\n\nactive treatment were randomly selected to participate in the 26-week Treatment Safety Extension. Several placebo-treated participants continued in error into the Treatment Safety Extension.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'BG000'}, {'value': '207', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}, {'value': '212', 'groupId': 'BG004'}, {'value': '1055', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'MF/F MDI 400/10 mcg BID', 'description': 'Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks'}, {'id': 'BG001', 'title': 'MF/F MDI 200/10 mcg BID', 'description': 'MF/F 200/10 mcg via a MDI BID for 52 weeks'}, {'id': 'BG002', 'title': 'MF MDI 400 mcg BID', 'description': 'Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks'}, {'id': 'BG003', 'title': 'F MDI 10 mcg BID', 'description': 'Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo MDI BID for 26 weeks'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '59.8', 'spread': '8.9', 'groupId': 'BG002'}, {'value': '59.6', 'spread': '8.5', 'groupId': 'BG003'}, {'value': '58.8', 'spread': '8.7', 'groupId': 'BG004'}, {'value': '59.8', 'spread': '8.7', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}, {'value': '237', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}, {'value': '152', 'groupId': 'BG003'}, {'value': '170', 'groupId': 'BG004'}, {'value': '818', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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': 1055}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2006-09-29', 'resultsFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2006-09-29', 'lastUpdatePostDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-08-29', 'studyFirstPostDateStruct': {'date': '2006-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Area Under the Time Curve From 0 to 12 Hours (AUC(0-12 Hours)) of Change From Baseline to Week 13 in Forced Expiratory Volume (Liters) in 1 Second (FEV1)', 'timeFrame': 'Baseline to Endpoint (13 weeks)', 'description': 'FEV1 AUC was standardized to liters. Endpoint was the last post-baseline non-missing result through Week 13 carried forward.'}, {'measure': 'Mean Change From Baseline to Week 13 Endpoint in AM Predose FEV1', 'timeFrame': 'Baseline to Endpoint (13 weeks)', 'description': 'Endpoint was the last post-baseline non-missing result through Week 13 carried\n\nforward.'}], 'secondaryOutcomes': [{'measure': "Change From Baseline to Endpoint in St George's Respiratory Questionaire (SGRQ) Total Score", 'timeFrame': 'Baseline to Endpoint (26 weeks)', 'description': 'SGRQ consisted of 76 items aggregated into 3 component scores: symptoms (frequency/severity), activity (cause or limited by breathlessness), impact (social functioning, psychological disturbances from airway disease), \\& total score. Best health scores have a low numeric value. All component scores \\& total score range from 0-100, with a higher score indicating greater disease burden. A 4-point increase over placebo (and Baseline) was considered the minimum clinically important difference. Endpoint is the last post-baseline non-missing result through the 26 week evaluation carried forward.'}, {'measure': 'Change From Baseline in Proportion of Chronic Obstructive Pulmonary Disease (COPD) Symptom-Free Nights (AM Diary Symptoms)', 'timeFrame': 'Baseline to Endpoint (26 weeks)', 'description': 'Prior to the use of study drug rescue medication (in the morning upon awakening) the participant evaluated the COPD symptoms of wheezing, cough, and difficulty breathing. A symptom-free night was defined as a combined score of 0 (no symptoms) across all three COPD symptoms evaluated the following morning. Proportion for Baseline included data from the last week before the first dose. Proportion for Endpoint included data across the entire 26-week treatment period.'}, {'measure': 'Number of Participants With Partly Stable COPD', 'timeFrame': 'Endpoint (26 weeks)', 'description': 'Partly stable COPD was a composite measure that included the following COPD\n\noutcomes: (1) No oral steroid rescue medication; (2) No AM or PM COPD weekly average symptom score greater than 2 during at least 7 of 8 weeks; (3) No moderate or severe exacerbations; (4) No unscheduled visits due to COPD worsenings; (5) No study discontinuation due to treatment failure or\n\ntreatment-related adverse event as determined by the investigator.'}, {'measure': 'Number of Participants With Mild, Moderate, or Severe COPD Exacerbations', 'timeFrame': 'Endpoint (26 weeks)', 'description': 'Mild = 12 or more inhalations/day of inhaled rescue medication or 2 or more nebulized treatments/day of inhaled rescue medication. Moderate = treatment with antibiotics or oral steroids. Severe = emergency room treatment or hospitalizations of survival curves. If an event was composed of multiple criteria, the most severe criteria was assigned to the event.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '25044280', 'type': 'DERIVED', 'citation': 'Maspero J, Cherrez I, Doherty DE, Tashkin DP, Kuna P, Kuo WL, Gates D, Nolte H, Chylack LT Jr. Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthma. Respir Med. 2014 Sep;108(9):1355-62. doi: 10.1016/j.rmed.2014.04.015. Epub 2014 May 2.'}, {'pmid': '22334770', 'type': 'DERIVED', 'citation': 'Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, Gates D, Staudinger H. Efficacy and safety characteristics of mometasone furoate/formoterol fumarate fixed-dose combination in subjects with moderate to very severe COPD: findings from pooled analysis of two randomized, 52-week placebo-controlled trials. Int J Chron Obstruct Pulmon Dis. 2012;7:73-86. doi: 10.2147/COPD.S29444. Epub 2012 Feb 3.'}, {'pmid': '22334768', 'type': 'DERIVED', 'citation': 'Tashkin DP, Doherty DE, Kerwin E, Matiz-Bueno CE, Knorr B, Shekar T, Banerjee S, Staudinger H. Efficacy and safety of a fixed-dose combination of mometasone furoate and formoterol fumarate in subjects with moderate to very severe COPD: results from a 52-week Phase III trial. Int J Chron Obstruct Pulmon Dis. 2012;7:43-55. doi: 10.2147/COPD.S27319. Epub 2012 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated\n\nsubjects who will not participate in the safety extension will be discontinued\n\nand will have their Final Visit at Week 26. Subjects who continue into the\n\n26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC\\[0-12hr\\]) and change from Baseline to Week 13 in AM predose FEV1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe COPD based on prebronchodilator FEV1/forced vital capacity (FVC) ratio of \\<=70%.\n* At Screening, postbronchodilator FEV1 must be \\<=60% predicted normal \\& \\>=25% predicted normal.\n* COPD symptoms for \\>=24 months.\n* Ex- or current smoker with smoking history \\>=10 pack years.\n* Only albuterol/salbutamol for relief for at least 2 weeks prior to randomization.\n* Withdraw from parenteral \\& oral steroids, anticholinergics, \\& antibiotics at least 4 weeks prior to Screening.\n* No harm in changing current COPD therapy, willing to discontinue his/her anticholinergics, inhaled corticosteroids (ICS) or ICS/long-acting beta agonists (LABA) at Screening, \\& transferred to albuterol/salbutamol for relief for 2 weeks prior to randomization.\n* Lab tests conducted at Screening must be acceptable to investigator. Electrocardiogram (ECG) performed at Screening Visit or within 30 days prior to Screening must be acceptable to investigator. Chest x-ray performed at Screening or within 12 months prior to Screening must be acceptable to investigator.\n* Women who have\n\nbeen surgically sterilized or are at least 1 year postmenopausal are not\n\nconsidered to be of childbearing potential. A female subject of childbearing\n\npotential must have a negative serum pregnancy test at Screening in order to\n\nbe considered eligible for enrollment. Female of childbearing potential must use birth control. Includes: hormonal contraceptives, intra-uterine device (IUD), condom in combination with spermicide, monogamous relationship with male partner who had vasectomy. Started birth control at least 3 months prior to Screening (exception condom), \\& agree to continue. Female who is not currently sexually active must agree/consent to use a method should she become sexually active. Women surgically sterilized or are at least 1 year postmenopausal are not considered to be of childbearing potential. Female must have negative serum pregnancy test at Screening.\n\nExclusion Criteria:\n\n* Evidence (upon visual inspection) of oropharyngeal candidiasis at Baseline with or without treatment. If there is evidence at Screening, may be treated as appropriate \\& visit can be scheduled upon resolution. If there is evidence at Baseline Visit, may be treated as appropriate \\& visit can be rescheduled upon resolution.\n* History of renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmological, respiratory, gastrointestinal, cerebrovascular, or other which could interfere with study or require treatment which might interfere with study. Examples include (but are not limited to) hypertension being treated with beta-blockers, active hepatitis, coronary artery disease, arrhythmia, significant QTc prolongation (ie QTcF or QTcB \\[Fridericia or Bazett corrections, respectively \\>500 milliseconds (msecs)\\]), stroke, severe rheumatoid arthritis, chronic open-angle glaucoma or posterior subcapsular cataracts, acquired immune deficiency syndrome (AIDS), or conditions that may interfere with respiratory function such as asthma, bronchiectasis, cystic fibrosis. Others which are well-controlled \\& stable (eg hypertension not requiring beta-blockers) will not prohibit participation if deemed appropriate per investigator.\n* Allergy/sensitivity to glucocorticosteroids, beta-2 agonists, study drug/excipients.\n* Female who is breast-feeding, pregnant, or intends to become pregnant.\n* Illicit drug user.\n* Human immunodeficiency virus (HIV) positive (testing not conducted).\n* Unable to correctly use oral MDI.\n* Taking any restricted medications prior to Screening without meeting washout.\n* Cannot adhere to permitted concomitant \\& prohibited medications.\n* May not participate in this same study at another investigational site. Cannot participate in different investigational study at any site, during same time of study.\n* Not be randomized into study more than once.\n* No person directly associated with administration of study may participate.\n* Previously participated in MF/F trial.\n* Increase in absolute volume of \\>=400 milliliters (mL) at Screening or prior to Baseline within 30 minutes after administration of 4 inhalations of albuterol/salbutamol (total dose of 360 to 400 mcg), or nebulized 2.5 mg albuterol/salbutamol.\n* Asthma.\n* Blood eosinophil count greater than 0.57 x 10\\^3/microliter (uL).\n* Lobectomy, pneumonectomy or lung volume reduction surgery.\n* Lung cancer.\n* Requires long-term administration of oxygen (\\>15 hours per day).\n* A subject who experiences an exacerbation of COPD requiring medical\n\nintervention within 4 weeks prior to randomization, beta-blocking agents, or\n\ntreatment with additional excluded medication (other than short-acting beta agonists (SABA)/short-acting\n\nanticholinergic to be used as rescue medication).\n\n* alpha-1-antitrypsin deficiency.\n* Cataract extractions on both eyes.\n* A history and/or presence of intraocular pressure in either eye \\>=22 millimeters of mercury (mm Hg), glaucoma, and/or posterior subcapsular cataracts. A subject who has undergone incisional or intraocular surgery in which the natural lens is still present in the eye. A subject with a history of penetrating trauma to both eyes. A subject with one or more of the following Lens Opacities Classification System (LOCS) III grades at screening:\n\nnuclear opalescence (NO): \\>=3.0,\n\nnuclear color (NC): \\>=3.0,\n\ncortical cataract (C): \\>=2.0,\n\nposterior subcapsular (P): \\>=0.5.'}, 'identificationModule': {'nctId': 'NCT00383435', 'briefTitle': 'Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, 26-Week, Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension, of High- and Medium-Dose Inhaled Mometasone Furoate/Formoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled Mometasone Furoate Monotherapy in Subjects With Moderate to Severe COPD', 'orgStudyIdInfo': {'id': 'P04229'}, 'secondaryIdInfos': [{'id': 'Doc ID: 3227334;'}, {'id': 'Eudract No: 2006-002308-32;'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MF/F MDI 400/10 mcg BID', 'interventionNames': ['Drug: Mometasone furoate/formoterol (MF/F) combination']}, {'type': 'EXPERIMENTAL', 'label': 'MF/F MDI 200/10 mcg BID', 'interventionNames': ['Drug: Mometasone furoate/formoterol (MF/F) combination']}, {'type': 'EXPERIMENTAL', 'label': 'MF MDI 400 mcg BID', 'interventionNames': ['Drug: Mometasone furoate MDI (MF MDI)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol MDI 10 mcg BID', 'interventionNames': ['Drug: Formoterol MDI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Mometasone furoate/formoterol (MF/F) combination', 'type': 'DRUG', 'otherNames': ['SCH 418131'], 'description': 'MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks', 'armGroupLabels': ['MF/F MDI 400/10 mcg BID']}, {'name': 'Mometasone furoate/formoterol (MF/F) combination', 'type': 'DRUG', 'otherNames': ['SCH 418131'], 'description': 'MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks', 'armGroupLabels': ['MF/F MDI 200/10 mcg BID']}, {'name': 'Mometasone furoate MDI (MF MDI)', 'type': 'DRUG', 'otherNames': ['SCH 32088'], 'description': 'MF 400 mcg via metered dose inhaler twice daily for 52 weeks', 'armGroupLabels': ['MF MDI 400 mcg BID']}, {'name': 'Formoterol MDI', 'type': 'DRUG', 'otherNames': ['Foradil'], 'description': 'Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks', 'armGroupLabels': ['Formoterol MDI 10 mcg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo MDI twice a day for 26 weeks', 'armGroupLabels': ['Placebo MDI BID']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}