Viewing Study NCT01854658

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Ignite Creation Date: 2025-12-25 @ 12:18 AM
Ignite Modification Date: 2026-01-03 @ 11:48 AM
Study NCT ID: NCT01854658
Status: COMPLETED
Last Update Posted: 2017-03-28
First Post: 2013-05-13
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': '973-975-0320', 'title': 'Colin Reisner, MD, FCCP, FAAAAI', '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 its 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 (AEs) and Serious Adverse Events (SAEs) will be collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.', 'description': 'Safety population included all participants who were administered investigational drug; participants were included in safety population according to the investigational drug received', 'eventGroups': [{'id': 'EG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID', 'otherNumAtRisk': 438, 'otherNumAffected': 21, 'seriousNumAtRisk': 438, 'seriousNumAffected': 37}, {'id': 'EG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID', 'otherNumAtRisk': 439, 'otherNumAffected': 12, 'seriousNumAtRisk': 439, 'seriousNumAffected': 37}, {'id': 'EG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID', 'otherNumAtRisk': 510, 'otherNumAffected': 22, 'seriousNumAtRisk': 510, 'seriousNumAffected': 36}, {'id': 'EG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID', 'otherNumAtRisk': 223, 'otherNumAffected': 10, 'seriousNumAtRisk': 223, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oropharyngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac pacemaker insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 438, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 439, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 510, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Morning Pre-dose Trough FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '350', 'groupId': 'OG000'}, {'value': '367', 'groupId': 'OG001'}, {'value': '433', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.061', 'groupId': 'OG000', 'lowerLimit': '0.039', 'upperLimit': '0.082'}, {'value': '0.063', 'groupId': 'OG001', 'lowerLimit': '0.041', 'upperLimit': '0.084'}, {'value': '0.116', 'groupId': 'OG002', 'lowerLimit': '0.097', 'upperLimit': '0.136'}, {'value': '0.013', 'groupId': 'OG003', 'lowerLimit': '-0.018', 'upperLimit': '0.044'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At Week 24', 'description': 'Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '434', 'groupId': 'OG001'}, {'value': '503', 'groupId': 'OG002'}, {'value': '216', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.080', 'groupId': 'OG000', 'lowerLimit': '0.064', 'upperLimit': '0.095'}, {'value': '0.082', 'groupId': 'OG001', 'lowerLimit': '0.067', 'upperLimit': '0.097'}, {'value': '0.137', 'groupId': 'OG002', 'lowerLimit': '0.123', 'upperLimit': '0.151'}, {'value': '0.008', 'groupId': 'OG003', 'lowerLimit': '-0.014', 'upperLimit': '0.030'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Over 24 weeks', 'description': 'Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Peak FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '346', 'groupId': 'OG000'}, {'value': '365', 'groupId': 'OG001'}, {'value': '431', 'groupId': 'OG002'}, {'value': '165', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.268', 'groupId': 'OG000', 'lowerLimit': '0.244', 'upperLimit': '0.292'}, {'value': '0.223', 'groupId': 'OG001', 'lowerLimit': '0.199', 'upperLimit': '0.247'}, {'value': '0.350', 'groupId': 'OG002', 'lowerLimit': '0.328', 'upperLimit': '0.371'}, {'value': '0.083', 'groupId': 'OG003', 'lowerLimit': '0.048', 'upperLimit': '0.117'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At week 24', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'St. George Respiratory Questionnaire (SGRQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}, {'value': '362', 'groupId': 'OG001'}, {'value': '430', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-1.1'}, {'value': '-2.2', 'groupId': 'OG001', 'lowerLimit': '-3.4', 'upperLimit': '-1.0'}, {'value': '-3.0', 'groupId': 'OG002', 'lowerLimit': '-4.1', 'upperLimit': '-1.8'}, {'value': '-1.2', 'groupId': 'OG003', 'lowerLimit': '-3.0', 'upperLimit': '0.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Change from baseline in the SGRQ total score at Week 24. 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': 'Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Rescue Ventolin HFA Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}, {'value': '438', 'groupId': 'OG001'}, {'value': '510', 'groupId': 'OG002'}, {'value': '223', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'groupId': 'OG000', 'lowerLimit': '-0.9', 'upperLimit': '-0.5'}, {'value': '-0.4', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '-0.3'}, {'value': '-1.0', 'groupId': 'OG002', 'lowerLimit': '-1.2', 'upperLimit': '-0.8'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '-0.2', 'upperLimit': '0.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 24 weeks', 'unitOfMeasure': 'Puffs / Day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Onset of Action as Assessed by FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}, {'value': '371', 'groupId': 'OG001'}, {'value': '429', 'groupId': 'OG002'}, {'value': '179', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'OG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'classes': [{'title': '5 min post dose', 'categories': [{'measurements': [{'value': '0.175', 'groupId': 'OG000', 'lowerLimit': '0.163', 'upperLimit': '0.188'}, {'value': '0.052', 'groupId': 'OG001', 'lowerLimit': '0.040', 'upperLimit': '0.065'}, {'value': '0.192', 'groupId': 'OG002', 'lowerLimit': '0.180', 'upperLimit': '0.204'}, {'value': '0.006', 'groupId': 'OG003', 'lowerLimit': '-0.012', 'upperLimit': '0.024'}]}]}, {'title': '15 min post dose', 'categories': [{'measurements': [{'value': '0.212', 'groupId': 'OG000', 'lowerLimit': '0.199', 'upperLimit': '0.225'}, {'value': '0.109', 'groupId': 'OG001', 'lowerLimit': '0.096', 'upperLimit': '0.122'}, {'value': '0.237', 'groupId': 'OG002', 'lowerLimit': '0.225', 'upperLimit': '0.249'}, {'value': '0.022', 'groupId': 'OG003', 'lowerLimit': '0.003', 'upperLimit': '0.040'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'At 5 min post dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'groupDescription': 'At 15 min post dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'At 5 min post dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG003'], 'groupDescription': 'At 15 min post dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'At 5 min post dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.0001', 'groupIds': ['OG002', 'OG003'], 'groupDescription': 'At 15 min post dose', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat population with evaluable data (no imputation) for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'FG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'FG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'FG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '440'}, {'groupId': 'FG002', 'numSubjects': '512'}, {'groupId': 'FG003', 'numSubjects': '224'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '365'}, {'groupId': 'FG002', 'numSubjects': '432'}, {'groupId': 'FG003', 'numSubjects': '165'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '80'}, {'groupId': 'FG003', 'numSubjects': '59'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '29'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Protocol-specified criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'Administrative reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Conducted at 140 sites throughout the United States from July 2013 - February 2015. Study participation was a maximum of 32 weeks.', 'preAssignmentDetails': 'A multicenter, randomized, double-blind, parallel group, chronic dosing, active- and placebo-controlled study; each participant was randomized to receive 1 of 4 possible treatments over the course of a 24-week treatment period (With a randomization of 7:6:6:3 GFF MDI, GP MDI, FF MDI and Placebo MDI)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'BG000'}, {'value': '439', 'groupId': 'BG001'}, {'value': '510', 'groupId': 'BG002'}, {'value': '223', 'groupId': 'BG003'}, {'value': '1609', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg administered as two puffs BID'}, {'id': 'BG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 14.4 mcg administered as two puffs BID'}, {'id': 'BG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 14.4/9.6 mcg administered as two puffs BID'}, {'id': 'BG003', 'title': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.6', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '62.8', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '62.8', 'spread': '8.2', 'groupId': 'BG002'}, {'value': '64.2', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '62.9', 'spread': '8.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '723', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}, {'value': '886', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '5 subjects participated in more than one Phase 3 Pearl study (a protocol violation) and had overlapping treatment exposure - these subjects were removed from the ITT and safety populations;\n\n1 subject participated in more than one Phase 3 Pearl study but did not have overlapping treatment exposure - this subject was removed from the ITT population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1615}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'dispFirstSubmitDate': '2015-07-07', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2013-05-13', 'dispFirstSubmitQcDate': '2015-07-07', 'resultsFirstSubmitDate': '2016-05-21', 'studyFirstSubmitQcDate': '2013-05-14', 'dispFirstPostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-07', 'studyFirstPostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1', 'timeFrame': 'At Week 24', 'description': 'Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks', 'timeFrame': 'Over 24 weeks', 'description': 'Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.'}, {'measure': 'Peak FEV1', 'timeFrame': 'At week 24', 'description': 'Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24'}, {'measure': 'St. George Respiratory Questionnaire (SGRQ) Score', 'timeFrame': '24 weeks', 'description': 'Change from baseline in the SGRQ total score at Week 24. 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': 'Rescue Ventolin HFA Use', 'timeFrame': '24 weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 24 weeks'}, {'measure': 'Onset of Action as Assessed by FEV1', 'timeFrame': 'Day 1', 'description': 'Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, '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': '28720336', 'type': 'DERIVED', 'citation': 'Martinez FJ, Fabbri LM, Ferguson GT, Orevillo C, Darken P, Martin UJ, Reisner C. Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD. Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4151&filename=PT003007-02%20Protocol%20Amendment-FINAL-11Sept14_29June16_Redacted.pdf', 'label': 'PT003007-02 Protocol Amendment-FINAL-Redacted.pdf'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Male or female subjects at least 40 years of age and no older than 80 at Visit 1.\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* Subjects with FEV1/FVC ratio of \\<0.70 and FEV1 \\<80% predicted normal and ≥750 mL if FEV1 \\<30% of predicted normal value.\n* Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol\n\nKey Exclusion Criteria:\n\n* Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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* Current diagnosis of asthma or alpha-1 antitrypsin deficiency\n* Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea\n* Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period\n* Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period\n* Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period\n* Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.\n* Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months\n* Congestive heart failure (CHF NYHA Class III/IV)\n* Clinically significant abnormal 12-lead ECG\n* Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing\n* Cancer not in complete remission for at least five years\n* History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI\n\nOther protocol-defined inclusion/exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT01854658', 'briefTitle': 'Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind (Test Products and Placebo), 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': 'PT003007-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FF MDI (PT005)', 'description': 'FF MDI administered as two puffs BID', 'interventionNames': ['Drug: FF MDI (PT005)']}, {'type': 'EXPERIMENTAL', 'label': 'GP MDI (PT001)', 'description': 'GP MDI administered as two puffs BID', 'interventionNames': ['Drug: GP MDI (PT001)']}, {'type': 'EXPERIMENTAL', 'label': 'GFF MDI (PT003)', 'description': 'GFF MDI administered as two puffs BID', 'interventionNames': ['Drug: GFF MDI (PT003)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI', 'description': 'Inhaled placebo administered as two puffs BID', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'GFF MDI (PT003)', 'type': 'DRUG', 'otherNames': ['glycopyrrolate/formoterol fumarate metered-dose inhaler', '(GFF MDI)'], 'description': 'GFF MDI administered as two puffs BID', 'armGroupLabels': ['GFF MDI (PT003)']}, {'name': 'GP MDI (PT001)', 'type': 'DRUG', 'otherNames': ['glycopyrrolate metered dose inhaler (GP MDI)'], 'description': 'GP MDI administered as two puffs BID', 'armGroupLabels': ['GP MDI (PT001)']}, {'name': 'FF MDI (PT005)', 'type': 'DRUG', 'otherNames': ['formoterol fumarate metered dose inhaler (FF MDI)'], 'description': 'FF MDI administered as two puffs BID', 'armGroupLabels': ['FF MDI (PT005)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo MDI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Florence', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 34.79981, 'lon': -87.67725}}, {'city': 'Jasper', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 33.83122, 'lon': -87.27751}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pearl Investigative Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Fullerton', 'state': 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