Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-07 @ 10:40 AM
Study NCT ID:
NCT02040792
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2014-01-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': {'description': 'One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK study with another investigational agent at the same time as their participation in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo', 'otherNumAtRisk': 71, 'otherNumAffected': 8, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '44 mcg', 'description': 'TD-4208\n\nTD-4208', 'otherNumAtRisk': 68, 'otherNumAffected': 1, 'seriousNumAtRisk': 68, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '88 mcg', 'description': 'TD-4208\n\nTD-4208', 'otherNumAtRisk': 71, 'otherNumAffected': 6, 'seriousNumAtRisk': 71, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '175 mcg', 'description': 'TD-4208\n\nTD-4208', 'otherNumAtRisk': 71, 'otherNumAffected': 10, 'seriousNumAtRisk': 71, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': '350 mcg', 'description': 'TD-4208\n\nTD-4208', 'otherNumAtRisk': 74, 'otherNumAffected': 15, 'seriousNumAtRisk': 74, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Angina Unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 71, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo'}, {'id': 'OG001', 'title': '44 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'OG002', 'title': '88 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'OG003', 'title': '175 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'OG004', 'title': '350 mcg', 'description': 'TD-4208\n\nTD-4208'}], 'classes': [{'categories': [{'measurements': [{'value': '-32.4', 'spread': '25.36', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '24.98', 'groupId': 'OG001'}, {'value': '155.0', 'spread': '24.61', 'groupId': 'OG002'}, {'value': '134.2', 'spread': '25.07', 'groupId': 'OG003'}, {'value': '138.2', 'spread': '24.38', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to 28 days', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo'}, {'id': 'FG001', 'title': '44 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'FG002', 'title': '88 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'FG003', 'title': '175 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'FG004', 'title': '350 mcg', 'description': 'TD-4208\n\nTD-4208'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '71'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '68'}, {'groupId': 'FG003', 'numSubjects': '64'}, {'groupId': 'FG004', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '7'}]}]}], 'preAssignmentDetails': 'One subject who received placebo was excluded from the efficacy analysis. The reason for this is that the subject was found to be participating in a GSK (GlaxoSmithKline) study with another investigational agent at the same time as their participation in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '71', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '354', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo'}, {'id': 'BG001', 'title': '44 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'BG002', 'title': '88 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'BG003', 'title': '175 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'BG004', 'title': '350 mcg', 'description': 'TD-4208\n\nTD-4208'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '9.17', 'groupId': 'BG000'}, {'value': '60.9', 'spread': '8.87', 'groupId': 'BG001'}, {'value': '60.4', 'spread': '7.98', 'groupId': 'BG002'}, {'value': '64.5', 'spread': '7.69', 'groupId': 'BG003'}, {'value': '61.4', 'spread': '8.98', 'groupId': 'BG004'}, {'value': '61.9', 'spread': '8.63', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '176', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '178', 'groupId': 'BG005'}]}]}], '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 355}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2014-01-16', 'resultsFirstSubmitDate': '2016-06-30', 'studyFirstSubmitQcDate': '2014-01-16', 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-13', 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Trough FEV1 (Forced Expiratory Volume in One Second)', 'timeFrame': 'Baseline to 28 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Chronic Obstructive Pulmonary Disease'], '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': '29096627', 'type': 'DERIVED', 'citation': 'Pudi KK, Barnes CN, Moran EJ, Haumann B, Kerwin E. A 28-day, randomized, double-blind, placebo-controlled, parallel group study of nebulized revefenacin in patients with chronic obstructive pulmonary disease. Respir Res. 2017 Nov 2;18(1):182. doi: 10.1186/s12931-017-0647-1.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated the safety and efficacy of four doses of TD-4208 and a placebo product when administered once daily for 28 days using a jet nebulizer to patients with moderate to severe chronic obstructive pulmonary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is a male or female subject 40 years of age or older\n* Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential\n* Subject is capable of performing reproducible spirometry maneuvers\n* Subject has post-bronchodilator FEV1/FVC ratio \\<0.7\n* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the GOLD Guidelines)\n* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal\n* Subject has a current or past smoking history of at least 10 pack-years.\n\nExclusion Criteria:\n\n* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study\n* Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergic or beta-agonist agents\n* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents\n* Subject has been hospitalized for COPD or pneumonia within 12 weeks\n* Subject requires long-term oxygen therapy (\\>15 hours a day)'}, 'identificationModule': {'nctId': 'NCT02040792', 'briefTitle': 'A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'A Phase 2B, 28-Day, Randomized, Double-Blind Placebo-Controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '0117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '44 mcg', 'description': 'TD-4208', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': '88 mcg', 'description': 'TD-4208', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': '175 mcg', 'description': 'TD-4208', 'interventionNames': ['Drug: TD-4208']}, {'type': 'EXPERIMENTAL', 'label': '350 mcg', 'description': 'TD-4208', 'interventionNames': ['Drug: TD-4208']}], 'interventions': [{'name': 'TD-4208', 'type': 'DRUG', 'otherNames': ['revefenacin'], 'armGroupLabels': ['175 mcg', '350 mcg', '44 mcg', '88 mcg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Upstate Pharmaceutical Research', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Medial Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}