Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-01-09 @ 9:42 PM
Study NCT ID:
NCT02343458
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D006024', 'term': 'Glycopyrrolate'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'creisner@pearltherapeutics.com', 'phone': '650-305-2600', 'title': 'Pearl Therapeutics Inc.', 'organization': 'Pearl Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': "Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time the subject signed consent throughout the four treatment periods of 24 weeks and up to 10 days following the last dose of study drug.', 'description': 'The Safety Population was defined as all subjects who were randomized to treatment regardless and received at least one dose of study treatment. Serious adverse events collected from the time the subject signed consent up to 14 days following the last dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug', 'otherNumAtRisk': 551, 'deathsNumAtRisk': 551, 'otherNumAffected': 166, 'seriousNumAtRisk': 551, 'deathsNumAffected': 1, 'seriousNumAffected': 53}, {'id': 'EG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug', 'otherNumAtRisk': 480, 'deathsNumAtRisk': 480, 'otherNumAffected': 123, 'seriousNumAtRisk': 480, 'deathsNumAffected': 1, 'seriousNumAffected': 40}, {'id': 'EG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation', 'otherNumAtRisk': 474, 'deathsNumAtRisk': 474, 'otherNumAffected': 128, 'seriousNumAtRisk': 474, 'deathsNumAffected': 1, 'seriousNumAffected': 34}, {'id': 'EG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 61, 'seriousNumAtRisk': 235, 'deathsNumAffected': 1, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 56, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 52, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 55, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 44, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma-chronic obstructive pulmonary disease overlap syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea Exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Borrelia Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes Zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Colitis ischemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 235, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 551, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 480, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 474, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 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TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2'}, {'type': 'SECONDARY', 'title': 'Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '490', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '412', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000', 'lowerLimit': '338', 'upperLimit': '378'}, {'value': '247', 'groupId': 'OG001', 'lowerLimit': '226', 'upperLimit': '269'}, {'value': '214', 'groupId': 'OG002', 'lowerLimit': '192', 'upperLimit': '235'}, {'value': '55', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '87'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at week 24', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach', 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}, {'type': 'SECONDARY', 'title': 'Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}, {'value': '436', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '368', 'groupId': 'OG000', 'lowerLimit': '350', 'upperLimit': '386'}, {'value': '255', 'groupId': 'OG001', 'lowerLimit': '236', 'upperLimit': '274'}, {'value': '228', 'groupId': 'OG002', 'lowerLimit': '209', 'upperLimit': '248'}, {'value': '70', 'groupId': 'OG003', 'lowerLimit': '42', 'upperLimit': '98'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over weeks 12-24', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach', 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}, {'type': 'SECONDARY', 'title': 'Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}, {'value': '474', 'groupId': 'OG002'}, {'value': '235', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000', 'lowerLimit': '360', 'upperLimit': '389'}, {'value': '277', 'groupId': 'OG001', 'lowerLimit': '261', 'upperLimit': '293'}, {'value': '234', 'groupId': 'OG002', 'lowerLimit': '218', 'upperLimit': '250'}, {'value': '82', 'groupId': 'OG003', 'lowerLimit': '58', 'upperLimit': '105'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 24 weeks', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach', 'unitOfMeasure': 'mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SGRQ Total Score at Week 24, US/China Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '489', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}, {'value': '412', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.3', 'groupId': 'OG000', 'lowerLimit': '-6.4', 'upperLimit': '-4.2'}, {'value': '-5.6', 'groupId': 'OG001', 'lowerLimit': '-6.8', 'upperLimit': '-4.4'}, {'value': '-3.7', 'groupId': 'OG002', 'lowerLimit': '-4.8', 'upperLimit': '-2.5'}, {'value': '-0.9', 'groupId': 'OG003', 'lowerLimit': '-2.6', 'upperLimit': '0.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at week 24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}, {'value': '436', 'groupId': 'OG002'}, {'value': '205', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'groupId': 'OG000', 'lowerLimit': '-6.1', 'upperLimit': '-4.3'}, {'value': '-5.0', 'groupId': 'OG001', 'lowerLimit': '-5.9', 'upperLimit': '-4.0'}, {'value': '-3.6', 'groupId': 'OG002', 'lowerLimit': '-4.6', 'upperLimit': '-2.6'}, {'value': '-1.7', 'groupId': 'OG003', 'lowerLimit': '-3.1', 'upperLimit': '-0.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over weeks 12-24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}, {'value': '92', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'groupId': 'OG000', 'lowerLimit': '-8.6', 'upperLimit': '-5.2'}, {'value': '-7.8', 'groupId': 'OG001', 'lowerLimit': '-9.7', 'upperLimit': '-5.9'}, {'value': '-3.8', 'groupId': 'OG002', 'lowerLimit': '-5.6', 'upperLimit': '-2.0'}, {'value': '-1.6', 'groupId': 'OG003', 'lowerLimit': '-4.3', 'upperLimit': '1.1'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'at week 24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2n'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '97', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.9', 'groupId': 'OG000', 'lowerLimit': '-8.4', 'upperLimit': '-5.4'}, {'value': '-7.3', 'groupId': 'OG001', 'lowerLimit': '-8.9', 'upperLimit': '-5.6'}, {'value': '-3.9', 'groupId': 'OG002', 'lowerLimit': '-5.5', 'upperLimit': '-2.4'}, {'value': '-3.1', 'groupId': 'OG003', 'lowerLimit': '-5.4', 'upperLimit': '-0.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over weeks 12-24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Symptomatic Population was defined as all subjects in the ITT Population with CAT scores of ≥15 at Visit 2'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches', 'denoms': [{'units': 'Participants', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}, {'value': '225', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '-1.1'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.3', 'upperLimit': '-0.7'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-0.9', 'upperLimit': '-0.3'}, {'value': '-0.4', 'groupId': 'OG003', 'lowerLimit': '-0.8', 'upperLimit': '-0.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'over 24 weeks', 'description': 'Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches', 'unitOfMeasure': 'Puffs/day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RVU Population - defined as Rescue Ventolin User'}, {'type': 'SECONDARY', 'title': 'FEV1 Measured at 5 Minutes Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '464', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '403', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.202', 'groupId': 'OG000', 'lowerLimit': '0.191', 'upperLimit': '0.212'}, {'value': '0.186', 'groupId': 'OG001', 'lowerLimit': '0.175', 'upperLimit': '0.197'}, {'value': '0.059', 'groupId': 'OG002', 'lowerLimit': '0.048', 'upperLimit': '0.070'}, {'value': '0.022', 'groupId': 'OG003', 'lowerLimit': '0.006', 'upperLimit': '0.038'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed at 5-minutes post dose on Day 1', 'description': 'Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}, {'type': 'SECONDARY', 'title': 'FEV1 Measured at 15 Minutes Post-dose on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '530', 'groupId': 'OG000'}, {'value': '458', 'groupId': 'OG001'}, {'value': '453', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'OG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'OG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'classes': [{'categories': [{'measurements': [{'value': '0.241', 'groupId': 'OG000', 'lowerLimit': '0.230', 'upperLimit': '0.252'}, {'value': '0.220', 'groupId': 'OG001', 'lowerLimit': '0.208', 'upperLimit': '0.231'}, {'value': '0.105', 'groupId': 'OG002', 'lowerLimit': '0.093', 'upperLimit': '0.117'}, {'value': '0.033', 'groupId': 'OG003', 'lowerLimit': '0.016', 'upperLimit': '0.050'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Assessed at 15-minute post dose on Day 1', 'description': 'Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population - defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects were analyzed according to the treatment they were assigned to at randomization. Number of participants analyzed reflects the ITT population with available data'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'FG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'FG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'FG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '555'}, {'groupId': 'FG001', 'numSubjects': '483'}, {'groupId': 'FG002', 'numSubjects': '480'}, {'groupId': 'FG003', 'numSubjects': '238'}]}, {'type': 'COMPLETED', 'comment': '1 subject has been captured in CSR who completed the study but had no follow up phone call.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '494'}, {'groupId': 'FG001', 'numSubjects': '417'}, {'groupId': 'FG002', 'numSubjects': '417'}, {'groupId': 'FG003', 'numSubjects': '200'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Protocol Specified Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'The study was conducted at 175 sites in the United States, United Kingdom, Taiwan (TW),South Korea (SK), Russia, Poland, Hungary, Germany, Czech Republic, China, and Japan from April 2015 to August 2017. The entire study period was scheduled to take approximately 30 weeks for each individual subject from the time of screening.', 'preAssignmentDetails': 'Subjects were randomized in a 7:6:6:3 scheme (GFF MDI, FF MDI, GP MDI, and Placebo MDI). Randomization was stratified by reversibility to Ventolin HFA and COPD disease severity (moderate vs severe or very severe) to ensure a similar distribution of treatment arms across stratum.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '551', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '474', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}, {'value': '1740', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'GFF MDI 14.4/9.6 ug', 'description': 'Glycopyrronium, Formoterol Fumarate, Metered Dose Inhalation 14.4/9.6 ug'}, {'id': 'BG001', 'title': 'FF MDI 9.6 ug', 'description': 'Formoterol Fumarate, Metered Dose Inhalation 9.6 ug'}, {'id': 'BG002', 'title': 'GP MDI 14.4 ug', 'description': 'Glycopyrronium 14.4 ug Metered Dose Inhalation'}, {'id': 'BG003', 'title': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhalation'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.7', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '64.1', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '8.1', 'groupId': 'BG002'}, {'value': '63.9', 'spread': '7.5', 'groupId': 'BG003'}, {'value': '64.2', 'spread': '7.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT Population'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '450', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '408', 'groupId': 'BG000'}, {'value': '365', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}, {'value': '1290', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The data reported from one site was not included in the final analysis'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '181', 'groupId': 'BG002'}, {'value': '92', 'groupId': 'BG003'}, {'value': '700', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '260', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}, {'value': '137', 'groupId': 'BG003'}, {'value': '987', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'ITT Population'}], 'populationDescription': 'The data reported from one site was not included in the final analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-20', 'size': 16029932, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-01-28T11:58', 'hasProtocol': True}, {'date': '2017-03-07', 'size': 7769643, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-01-28T11:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1756}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2015-01-06', 'resultsFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-28', 'studyFirstPostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)', 'timeFrame': 'at week 24', 'description': 'For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment'}, {'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach', 'timeFrame': 'over weeks 12-24', 'description': 'Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach'}, {'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.', 'timeFrame': 'over 24 weeks', 'description': 'Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.'}], 'secondaryOutcomes': [{'measure': 'TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach', 'timeFrame': 'over 24 Weeks', 'description': "TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9"}, {'measure': 'TDI Focal Score Over Weeks 12-24 Japan Approach', 'timeFrame': 'over Weeks 12-24', 'description': "TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9"}, {'measure': 'TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population', 'timeFrame': 'over 24 Weeks', 'description': "TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9"}, {'measure': 'TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population', 'timeFrame': 'over weeks 12-24', 'description': "TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9"}, {'measure': 'Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach', 'timeFrame': 'at week 24', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach'}, {'measure': 'Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach', 'timeFrame': 'over weeks 12-24', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach'}, {'measure': 'Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach', 'timeFrame': 'over 24 weeks', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach'}, {'measure': 'Change From Baseline in SGRQ Total Score at Week 24, US/China Approach', 'timeFrame': 'at week 24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life'}, {'measure': 'Change From Baseline in SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach', 'timeFrame': 'over weeks 12-24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life'}, {'measure': 'Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach', 'timeFrame': 'at week 24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life'}, {'measure': 'Change From Baseline in SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach', 'timeFrame': 'over weeks 12-24', 'description': 'Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life'}, {'measure': 'Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches', 'timeFrame': 'over 24 weeks', 'description': 'Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches'}, {'measure': 'FEV1 Measured at 5 Minutes Post-dose on Day 1', 'timeFrame': 'Assessed at 5-minutes post dose on Day 1', 'description': 'Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant'}, {'measure': 'FEV1 Measured at 15 Minutes Post-dose on Day 1', 'timeFrame': 'Assessed at 15-minute post dose on Day 1', 'description': 'Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '35815359', 'type': 'DERIVED', 'citation': 'Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.'}, {'pmid': '32450869', 'type': 'DERIVED', 'citation': "Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y."}, {'pmid': '32021148', 'type': 'DERIVED', 'citation': 'Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.'}, {'pmid': '32021143', 'type': 'DERIVED', 'citation': 'Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014%20Statistical%20Analysis%20Plan%2011_01_01%20_Redacted%20updated%2020181003%20PDFA.pdf', 'label': 'Updated cover page'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014-05-%20CLINICAL%20STUDY%20PROTOCOL%20Redacted_updated%2020181003%20PDFA.pdf', 'label': 'Updated Cover page'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014-05-%20CLINICAL%20STUDY%20PROTOCOL%20Redacted%20PDFA.pdf', 'label': 'Updated Cover page'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014%20Statistical%20Analysis%20Plan%20PDFA.pdf', 'label': 'Updated cover page'}]}, 'descriptionModule': {'briefSummary': 'A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.', 'detailedDescription': 'A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.\n* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).\n* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.\n* Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of \\<0.70.\n* FEV1 must be \\<80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).\n\nExclusion Criteria:\n\n* Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.\n* Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.\n* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.\n* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).\n* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).\n* Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.\n* Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI."}, 'identificationModule': {'nctId': 'NCT02343458', 'briefTitle': 'Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo', 'orgStudyIdInfo': {'id': 'PT003014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GFF MDI (PT003)', 'description': 'Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)', 'interventionNames': ['Drug: GFF MDI (PT003)']}, {'type': 'EXPERIMENTAL', 'label': 'FF MDI (PT005)', 'description': 'Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)', 'interventionNames': ['Drug: FF MDI (PT005)']}, {'type': 'EXPERIMENTAL', 'label': 'GP MDI (PT001)', 'description': 'Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)', 'interventionNames': ['Drug: GP MDI (PT001)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI', 'description': 'Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)', 'interventionNames': ['Drug: Placebo MDI']}], 'interventions': [{'name': 'GFF MDI (PT003)', 'type': 'DRUG', 'otherNames': ['Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol'], 'description': 'Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)', 'armGroupLabels': ['GFF MDI (PT003)']}, {'name': 'FF MDI (PT005)', 'type': 'DRUG', 'otherNames': ['Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol'], 'description': 'Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)', 'armGroupLabels': ['FF MDI (PT005)']}, {'name': 'GP MDI (PT001)', 'type': 'DRUG', 'otherNames': ['Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol'], 'description': 'Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)', 'armGroupLabels': ['GP MDI (PT001)']}, {'name': 'Placebo MDI', 'type': 'DRUG', 'otherNames': ['Placebo (matching) for GFF MDI, FF MDI, and GP MDI'], 'description': 'Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)', 'armGroupLabels': ['Placebo MDI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36535', 'city': 'Foley', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.40659, 'lon': -87.6836}}, {'zip': '35501', 'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 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