Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-27 @ 12:36 AM
Study NCT ID:
NCT01704404
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2012-10-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}, {'id': 'D004646', 'term': 'Emphysema'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C583570', 'term': 'revefenacin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@theravance.com', 'phone': '1-855-633-8479', 'title': 'Head of Clinical Development & Medical Affairs', 'organization': 'Theravance Biopharma'}, 'certainAgreement': {'otherDetails': 'The PI may communicate the trial results generated by the PI, but only after the first publication or presentation of the combined study results generated by all participating sites. The Sponsor can then review trial results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The Sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '13 weeks', 'description': 'The Participant Flow shows the # of subjs in each of the 6 treatment sequences (each sequence has 4 treatments; 4/6 study drug doses and placebo) as instructed by CTgov for complex crossover designs. The Number of Participants at Risk, instead, shows the # of subjs exposed to each of the 6 doses of study drug and placebo. Also, some subjs did not complete all of the doses in their treatment sequence. The # of subjs in each sequence is not related to the # of subjs in each dose level therefore.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose 1 TD-4208', 'description': '22 µg\n\nTD-4208', 'otherNumAtRisk': 41, 'otherNumAffected': 14, 'seriousNumAtRisk': 42, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Dose 2 TD-4208', 'description': '44 µg\n\nTD-4208', 'otherNumAtRisk': 39, 'otherNumAffected': 12, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose 3 TD-4208', 'description': '88 µg\n\nTD-4208', 'otherNumAtRisk': 40, 'otherNumAffected': 12, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose 4 TD-4208', 'description': '175 µg\n\nTD-4208', 'otherNumAtRisk': 37, 'otherNumAffected': 13, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose 5 TD-4208', 'description': '350 µg\n\nTD-4208', 'otherNumAtRisk': 41, 'otherNumAffected': 8, 'seriousNumAtRisk': 41, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Dose 6 TD-4208', 'description': '700 µg\n\nTD-4208', 'otherNumAtRisk': 37, 'otherNumAffected': 9, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo', 'otherNumAtRisk': 61, 'otherNumAffected': 16, 'seriousNumAtRisk': 62, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 62, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}, {'value': '59', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 TD-4208', 'description': '22 µg\n\nTD-4208'}, {'id': 'OG001', 'title': 'Dose 2 TD-4208', 'description': '44 µg\n\nTD-4208'}, {'id': 'OG002', 'title': 'Dose 3 TD-4208', 'description': '88 µg\n\nTD-4208'}, {'id': 'OG003', 'title': 'Dose 4 TD-4208', 'description': '175 µg\n\nTD-4208'}, {'id': 'OG004', 'title': 'Dose 5 TD-4208', 'description': '350 µg\n\nTD-4208'}, {'id': 'OG005', 'title': 'Dose 6 TD-4208', 'description': '700 µg\n\nTD-4208'}, {'id': 'OG006', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'spread': '19.21', 'groupId': 'OG000'}, {'value': '92.8', 'spread': '20.25', 'groupId': 'OG001'}, {'value': '113.1', 'spread': '19.55', 'groupId': 'OG002'}, {'value': '151.9', 'spread': '19.99', 'groupId': 'OG003'}, {'value': '132.2', 'spread': '19.02', 'groupId': 'OG004'}, {'value': '119.4', 'spread': '19.54', 'groupId': 'OG005'}, {'value': '37.8', 'spread': '16.93', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to day 7', 'unitOfMeasure': 'FEV1 (mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 TD-4208', 'description': '22 µg\n\nTD-4208'}, {'id': 'OG001', 'title': 'Dose 2 TD-4208', 'description': '44 µg\n\nTD-4208'}, {'id': 'OG002', 'title': 'Dose 3 TD-4208', 'description': '88 µg\n\nTD-4208'}, {'id': 'OG003', 'title': 'Dose 4 TD-4208', 'description': '175 µg\n\nTD-4208'}, {'id': 'OG004', 'title': 'Dose 5 TD-4208', 'description': '350 µg\n\nTD-4208'}, {'id': 'OG005', 'title': 'Dose 6 TD-4208', 'description': '700 µg\n\nTD-4208'}], 'classes': [{'categories': [{'measurements': [{'value': '.0125', 'spread': '.00627', 'groupId': 'OG000'}, {'value': '.0224', 'spread': '.00864', 'groupId': 'OG001'}, {'value': '.0526', 'spread': '.0214', 'groupId': 'OG002'}, {'value': '.114', 'spread': '.0488', 'groupId': 'OG003'}, {'value': '.243', 'spread': '.104', 'groupId': 'OG004'}, {'value': '.577', 'spread': '.261', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to day 7', 'description': 'Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.\n\nDay 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Tmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 TD-4208', 'description': '22 µg\n\nTD-4208'}, {'id': 'OG001', 'title': 'Dose 2 TD-4208', 'description': '44 µg\n\nTD-4208'}, {'id': 'OG002', 'title': 'Dose 3 TD-4208', 'description': '88 µg\n\nTD-4208'}, {'id': 'OG003', 'title': 'Dose 4 TD-4208', 'description': '175 µg\n\nTD-4208'}, {'id': 'OG004', 'title': 'Dose 5 TD-4208', 'description': '350 µg\n\nTD-4208'}, {'id': 'OG005', 'title': 'Dose 6 TD-4208', 'description': '700 µg\n\nTD-4208'}], 'classes': [{'categories': [{'measurements': [{'value': '.233', 'spread': '.217', 'groupId': 'OG000'}, {'value': '.233', 'spread': '0.200', 'groupId': 'OG001'}, {'value': '0.233', 'spread': '0.200', 'groupId': 'OG002'}, {'value': '0.233', 'spread': '0.200', 'groupId': 'OG003'}, {'value': '0.233', 'spread': '0.217', 'groupId': 'OG004'}, {'value': '0.233', 'spread': '0.200', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to day 7', 'description': 'Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.\n\nDay 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Plasma Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose 1 TD-4208', 'description': '22 µg\n\nTD-4208'}, {'id': 'OG001', 'title': 'Dose 2 TD-4208', 'description': '44 µg\n\nTD-4208'}, {'id': 'OG002', 'title': 'Dose 3 TD-4208', 'description': '88 µg\n\nTD-4208'}, {'id': 'OG003', 'title': 'Dose 4 TD-4208', 'description': '175 µg\n\nTD-4208'}, {'id': 'OG004', 'title': 'Dose 5 TD-4208', 'description': '350 µg\n\nTD-4208'}, {'id': 'OG005', 'title': 'Dose 6 TD-4208', 'description': '700 µg\n\nTD-4208'}], 'classes': [{'categories': [{'measurements': [{'value': '25.1', 'spread': '7.89', 'groupId': 'OG004'}, {'value': '23.0', 'spread': '7.05', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to day 7', 'description': 'Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.\n\nDay 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of subjects reported for plasma half lives are based on the actual evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment 1', 'description': 'Placebo, 44 µg, 88 µg, 350 µg, 700 µg'}, {'id': 'FG001', 'title': 'Treatment 2', 'description': 'Placebo, 22 µg, 88 µg, 350 µg, 700 µg'}, {'id': 'FG002', 'title': 'Treatment 3', 'description': 'Placebo, 22 µg, 88 µg, 175 µg, 700 µg'}, {'id': 'FG003', 'title': 'Treatment 4', 'description': '22 µg, 44 µg, 175 µg, 700 µg'}, {'id': 'FG004', 'title': 'Treatment 5', 'description': '22 µg, 44 µg, 175 µg, 350 µg'}, {'id': 'FG005', 'title': 'Treatment 6', 'description': 'Placebo, 44 µg, 88 µg, 175 µg, 350 µg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'All subjects received Placebo and 4 of 6 TD-4208 dose levels:\n\nTD-4208 - 22 µg TD-4208 - 44 µg TD-4208 - 88 µg TD-4208 - 175 µg TD-4208 - 350 µg TD-4208 - 700 µg'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '6.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2012-10-04', 'resultsFirstSubmitDate': '2017-01-17', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-20', 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cmax', 'timeFrame': 'From baseline to day 7', 'description': 'Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.\n\nDay 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.'}, {'measure': 'Tmax', 'timeFrame': 'From baseline to day 7', 'description': 'Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.\n\nDay 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.'}, {'measure': 'Plasma Half-life', 'timeFrame': 'From baseline to day 7', 'description': 'Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.\n\nDay 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)', 'timeFrame': 'From baseline to day 7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Long acting muscarinic antagonist', 'Chronic Bronchitis', 'Emphysema', 'Chronic Obstructive Pulmonary Disease', 'COPD'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '33124005', 'type': 'DERIVED', 'citation': 'Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.'}, {'pmid': '28987804', 'type': 'DERIVED', 'citation': 'Quinn D, Barnes CN, Yates W, Bourdet DL, Moran EJ, Potgieter P, Nicholls A, Haumann B, Singh D. Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): Results of two randomized, double-blind, phase 2 studies. Pulm Pharmacol Ther. 2018 Feb;48:71-79. doi: 10.1016/j.pupt.2017.10.003. Epub 2017 Oct 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).\n2. Subject:\n\n * Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) \\<0.7 at screening; and\n * Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value.\n3. Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.\n4. Females of non-childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.\n5. Subject (or care giver) is able to properly prepare and administer study medication.\n6. Subject is willing and able to give written informed consent to participate.\n\nExclusion Criteria:\n\n1. Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.\n2. Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response test.\n3. Subject is taking daily maintenance inhaled/systemic corticosteroids (\\>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).\n4. Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.\n5. Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value \\>450 msec (males) or \\>470 msec (females); or shows evidence of clinically significant rhythm abnormality.\n6. Subject has a known hypersensitivity to TD-4208 or similar drug class.\n7. Subject has a history of alcoholism or drug abuse within 2 years prior to screening."}, 'identificationModule': {'nctId': 'NCT01704404', 'briefTitle': '7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'A Phase 2 Study of the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD-4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '0091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 TD-4208', 'description': '22 µg', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 TD-4208', 'description': '44 µg', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 TD-4208', 'description': '88 µg', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4 TD-4208', 'description': '175 µg', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 5 TD-4208', 'description': '350 µg', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 6 TD-4208', 'description': '700 µg', 'interventionNames': ['Drug: TD-4208']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'TD-4208', 'type': 'DRUG', 'otherNames': ['revefenacin'], 'armGroupLabels': ['Dose 1 TD-4208', 'Dose 2 TD-4208', 'Dose 3 TD-4208', 'Dose 4 TD-4208', 'Dose 5 TD-4208', 'Dose 6 TD-4208']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wellington', 'country': 'New Zealand', 'facility': 'P3 Research Ltd', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}