Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-04-14 @ 2:05 PM
Study NCT ID:
NCT02465567
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2015-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'South Korea']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', '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': 'Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized', 'description': 'The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug', 'eventGroups': [{'id': 'EG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg', 'otherNumAtRisk': 2144, 'deathsNumAtRisk': 2144, 'otherNumAffected': 337, 'seriousNumAtRisk': 2144, 'deathsNumAffected': 27, 'seriousNumAffected': 426}, {'id': 'EG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg', 'otherNumAtRisk': 2124, 'deathsNumAtRisk': 2124, 'otherNumAffected': 361, 'seriousNumAtRisk': 2124, 'deathsNumAffected': 42, 'seriousNumAffected': 445}, {'id': 'EG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg', 'otherNumAtRisk': 2125, 'deathsNumAtRisk': 2125, 'otherNumAffected': 292, 'seriousNumAtRisk': 2125, 'deathsNumAffected': 47, 'seriousNumAffected': 433}, {'id': 'EG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg', 'otherNumAtRisk': 2136, 'deathsNumAtRisk': 2136, 'otherNumAffected': 336, 'seriousNumAtRisk': 2136, 'deathsNumAffected': 35, 'seriousNumAffected': 440}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 290, 'numAffected': 227}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 315, 'numAffected': 239}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 255, 'numAffected': 199}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 331, 'numAffected': 234}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 149, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 176, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 129, 'numAffected': 102}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 154, 'numAffected': 115}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 255, 'numAffected': 202}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 263, 'numAffected': 221}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 268, 'numAffected': 219}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 299, 'numAffected': 241}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary emboism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 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{'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vocal cord leukoplakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchial secretion retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cystic lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pleurtitic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary calcification', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 63, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 64, 'numAffected': 59}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 37, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 57, 'numAffected': 55}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 2124, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 2125, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 2136, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2144, 'numEvents': 4, 'numAffected': 4}, 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'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'OG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '1026', 'groupId': 'OG000'}, {'value': '1013', 'groupId': 'OG001'}, {'value': '1056', 'groupId': 'OG002'}, {'value': '1085', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0035', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.880', 'ciLowerLimit': '0.807', 'ciUpperLimit': '0.959', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.887', 'ciLowerLimit': '0.814', 'ciUpperLimit': '0.966', 'statisticalMethod': 'Regression, Cox', 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'Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1425', 'groupId': 'OG000'}, {'value': '1389', 'groupId': 'OG001'}, {'value': '1387', 'groupId': 'OG002'}, {'value': '1426', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg'}, {'id': 'OG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg'}, {'id': 'OG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'OG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '-1.1'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-1.2', 'upperLimit': '-0.9'}, {'value': '-0.7', 'groupId': 'OG002', 'lowerLimit': '-0.8', 'upperLimit': '-0.5'}, {'value': '-0.8', 'groupId': 'OG003', 'lowerLimit': '-0.9', 'upperLimit': '-0.7'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '-0.34', 'statisticalMethod': 'Linear Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-0.54', 'ciUpperLimit': '-0.20', 'statisticalMethod': 'Linear Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 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'Participants', 'counts': [{'value': '2119', 'groupId': 'OG000'}, {'value': '2102', 'groupId': 'OG001'}, {'value': '2096', 'groupId': 'OG002'}, {'value': '2122', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg'}, {'id': 'OG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg'}, {'id': 'OG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'OG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '1068', 'groupId': 'OG000'}, {'value': '1024', 'groupId': 'OG001'}, {'value': '893', 'groupId': 'OG002'}, {'value': '949', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.358', 'ciLowerLimit': '1.199', 'ciUpperLimit': '1.539', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.246', 'ciLowerLimit': '1.100', 'ciUpperLimit': '1.410', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.0004', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.283', 'ciLowerLimit': '1.133', 'ciUpperLimit': '1.454', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0103', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.177', 'ciLowerLimit': '1.039', 'ciUpperLimit': '1.333', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at Week 24', 'description': "Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Time to Death (All Cause)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2137', 'groupId': 'OG000'}, {'value': '2121', 'groupId': 'OG001'}, {'value': '2120', 'groupId': 'OG002'}, {'value': '2131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg'}, {'id': 'OG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg'}, {'id': 'OG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'OG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.0111', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.544', 'ciLowerLimit': '0.340', 'ciUpperLimit': '0.870', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3401', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.782', 'ciLowerLimit': '0.472', 'ciUpperLimit': '1.296', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2690', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.789', 'ciLowerLimit': '0.518', 'ciUpperLimit': '1.201', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5918', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.134', 'ciLowerLimit': '0.716', 'ciUpperLimit': '1.796', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '52 Weeks', 'description': 'Subject Deaths (all cause)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Rate of Severe COPD Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2137', 'groupId': 'OG000'}, {'value': '2121', 'groupId': 'OG001'}, {'value': '2120', 'groupId': 'OG002'}, {'value': '2131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg'}, {'id': 'OG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg'}, {'id': 'OG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'OG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.15', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '0.16', 'spread': '0.01', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6552', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.03', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0221', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.97', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2157', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.08', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0647', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.01', 'statisticalMethod': 'Negative Binomial Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '52 Weeks', 'description': 'Rate of severe COPD exacerbations', 'unitOfMeasure': 'Severe Exacerbations', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg'}, {'id': 'FG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg'}, {'id': 'FG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'FG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2157'}, {'groupId': 'FG001', 'numSubjects': '2137'}, {'groupId': 'FG002', 'numSubjects': '2143'}, {'groupId': 'FG003', 'numSubjects': '2151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1708'}, {'groupId': 'FG001', 'numSubjects': '1713'}, {'groupId': 'FG002', 'numSubjects': '1580'}, {'groupId': 'FG003', 'numSubjects': '1643'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '449'}, {'groupId': 'FG001', 'numSubjects': '424'}, {'groupId': 'FG002', 'numSubjects': '563'}, {'groupId': 'FG003', 'numSubjects': '508'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '113'}, {'groupId': 'FG002', 'numSubjects': '147'}, {'groupId': 'FG003', 'numSubjects': '138'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '171'}, {'groupId': 'FG003', 'numSubjects': '135'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '123'}, {'groupId': 'FG003', 'numSubjects': '130'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '38'}, {'groupId': 'FG003', 'numSubjects': '28'}]}, {'type': 'Major Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Protocol Specified Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'Administrative Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'enrolled in >1 studies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'missing PI Signature', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in 26 countries between July 2015 and July 2019.', 'preAssignmentDetails': 'Subjects who successfully complete the Screening Period will then be randomized in a 1:1:1:1 scheme to BGF MDI 320/14.4/9.6 μg BID, BGF MDI 160/14.4/9.6 μg BID, BFF MDI 320/9.6 μg BID, or GFF MDI 14.4/9.6 μg BID, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2137', 'groupId': 'BG000'}, {'value': '2121', 'groupId': 'BG001'}, {'value': '2120', 'groupId': 'BG002'}, {'value': '2131', 'groupId': 'BG003'}, {'value': '8509', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BGF MDI 320/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg'}, {'id': 'BG001', 'title': 'BGF MDI 160/14.4/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg'}, {'id': 'BG002', 'title': 'GFF MDI 14.4/9.6 μg', 'description': 'Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg'}, {'id': 'BG003', 'title': 'BFF MDI 320/9.6 μg', 'description': 'Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.6', 'spread': '7.6', 'groupId': 'BG000'}, {'value': '64.6', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '7.6', 'groupId': 'BG002'}, {'value': '64.6', 'spread': '7.6', 'groupId': 'BG003'}, {'value': '64.7', 'spread': '7.6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '877', 'groupId': 'BG000'}, {'value': '823', 'groupId': 'BG001'}, {'value': '876', 'groupId': 'BG002'}, {'value': '852', 'groupId': 'BG003'}, {'value': '3428', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1260', 'groupId': 'BG000'}, {'value': '1298', 'groupId': 'BG001'}, {'value': '1244', 'groupId': 'BG002'}, {'value': '1279', 'groupId': 'BG003'}, {'value': '5081', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '393', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}, {'value': '401', 'groupId': 'BG003'}, {'value': '1620', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1690', 'groupId': 'BG000'}, {'value': '1680', 'groupId': 'BG001'}, {'value': '1649', 'groupId': 'BG002'}, {'value': '1683', 'groupId': 'BG003'}, {'value': '6702', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '142', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}, {'value': '651', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '1819', 'groupId': 'BG000'}, {'value': '1783', 'groupId': 'BG001'}, {'value': '1808', 'groupId': 'BG002'}, {'value': '1816', 'groupId': 'BG003'}, {'value': '7226', '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': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'mITT population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-21', 'size': 10748445, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-01T03:12', 'hasProtocol': True}, {'date': '2019-04-30', 'size': 3992713, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-01T03:13', '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': 8588}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'dispFirstSubmitDate': '2020-05-21', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2015-05-29', 'dispFirstSubmitQcDate': '2020-06-09', 'resultsFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2015-06-05', 'dispFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-01', 'studyFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Rate of Moderate or Severe Exacerbations', 'timeFrame': '52-week treatment period', 'description': 'Adjusted Rate of Moderate or Severe Exacerbations'}], 'secondaryOutcomes': [{'measure': 'Time to First Moderate or Severe COPD Exacerbation', 'timeFrame': '52 Weeks', 'description': 'Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)'}, {'measure': 'Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks', 'timeFrame': '24 Weeks', 'description': 'Change from baseline in average daily rescue Ventolin HFA use over 24 weeks'}, {'measure': 'Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score', 'timeFrame': 'at Week 24', 'description': "Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24"}, {'measure': 'Time to Death (All Cause)', 'timeFrame': '52 Weeks', 'description': 'Subject Deaths (all cause)'}, {'measure': 'Rate of Severe COPD Exacerbations', 'timeFrame': '52 Weeks', 'description': 'Rate of severe COPD exacerbations'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '39691156', 'type': 'DERIVED', 'citation': 'Muro S, Seki M, Hurst JR, Petullo D, Marshall J, Bowen K, Darken PF, Duncan EA, Megally A, Patel M. Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOS. Int J Chron Obstruct Pulmon Dis. 2024 Dec 12;19:2729-2737. doi: 10.2147/COPD.S478349. eCollection 2024.'}, {'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': '35614467', 'type': 'DERIVED', 'citation': 'Rhodes K, Jenkins M, de Nigris E, Aurivillius M, Ouwens M. Relationship between risk, cumulative burden of exacerbations and mortality in patients with COPD: modelling analysis using data from the ETHOS study. BMC Med Res Methodol. 2022 May 25;22(1):150. doi: 10.1186/s12874-022-01616-7.'}, {'pmid': '32579807', 'type': 'DERIVED', 'citation': 'Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Aurivillius M, Reisner C, Dorinsky P; ETHOS Investigators. Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD. N Engl J Med. 2020 Jul 2;383(1):35-48. doi: 10.1056/NEJMoa1916046. Epub 2020 Jun 24.'}, {'pmid': '31605923', 'type': 'DERIVED', 'citation': 'Rabe KF, Martinez FJ, Ferguson GT, Wang C, Singh D, Wedzicha JA, Trivedi R, St Rose E, Ballal S, McLaren J, Darken P, Reisner C, Dorinsky P. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 mug and 160/18/9.6 mug using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. Respir Med. 2019 Oct-Nov;158:59-66. doi: 10.1016/j.rmed.2019.08.010. Epub 2019 Aug 22.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.', 'detailedDescription': 'A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.'}, '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 (FEV1)/Forced vital capacity (FVC) ratio must be \\<0.70 and FEV1 must be \\<65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).\n* Subjects with history of exacerbations.\n\nPlease refer to the study protocol for the complete inclusion criteria list.\n\nExclusion Criteria\n\n* Significant diseases or conditions other than COPD, 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 are planning to become pregnant during the course of the study, 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)\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)\n* Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.\n* Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.\n* Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.\n\nPlease refer to the study protocol for the complete inclusion criteria list."}, 'identificationModule': {'nctId': 'NCT02465567', 'briefTitle': 'Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)', 'orgStudyIdInfo': {'id': 'PT010005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGF (PT010) MDI 320/14.4/9.6 μg', 'description': 'BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \\[MDI\\])', 'interventionNames': ['Drug: BGF MDI 320/14.4/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'BGF (PT010) MDI 160/14.4/9.6 μg', 'description': 'BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \\[MDI\\])', 'interventionNames': ['Drug: BGF MDI 160/14.4/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'BFF (PT009) MDI 320/9.6 μg', 'description': 'BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)', 'interventionNames': ['Drug: BFF MDI 320/9.6 μg']}, {'type': 'EXPERIMENTAL', 'label': 'GFF (PT003) MDI 14.4/9.6 μg', 'description': 'GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)', 'interventionNames': ['Drug: GFF MDI 14.4/9.6 μg']}], 'interventions': [{'name': 'BGF MDI 320/14.4/9.6 μg', 'type': 'DRUG', 'otherNames': ['BGF'], 'description': 'Budensonide, Glycopyrronium, and Formoterol Fumarate', 'armGroupLabels': ['BGF (PT010) MDI 320/14.4/9.6 μg']}, {'name': 'GFF MDI 14.4/9.6 μg', 'type': 'DRUG', 'otherNames': ['GFF'], 'description': 'Glycopyrronium, and Formoterol Fumarate', 'armGroupLabels': ['GFF (PT003) MDI 14.4/9.6 μg']}, {'name': 'BGF MDI 160/14.4/9.6 μg', 'type': 'DRUG', 'otherNames': ['BGF'], 'description': 'Budensonide, Glycopyrronium, and Formoterol Fumarate', 'armGroupLabels': ['BGF (PT010) MDI 160/14.4/9.6 μg']}, {'name': 'BFF MDI 320/9.6 μg', 'type': 'DRUG', 'otherNames': ['BFF'], 'description': 'Budensonide, and Formoterol Fumarate', 'armGroupLabels': ['BFF (PT009) MDI 320/9.6 μg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '35611', 'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 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