Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-25 @ 7:54 AM
Study NCT ID:
NCT03095456
Status:
COMPLETED
Last Update Posted:
2022-02-24
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
Sponsor:
Organization:
Raw JSON
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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. 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'PRIMARY', 'title': 'Change From Baseline in Trough FEV1 on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Revefenacin', 'description': 'Active Revefenacin and placebo (in place of Spiriva Handihaler®)\n\nRevefenacin: Revefenacin administered via nebulization.\n\nPlacebo for Spiriva Handihaler®: Placebo administered as double blind, double dummy via Spiriva HandiHaler®.'}, {'id': 'OG001', 'title': 'Spiriva Handihaler®', 'description': 'Active Spiriva Handihaler® and placebo (in place of Revefenacin)\n\nSpiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.\n\nPlacebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'spread': '20.17', 'groupId': 'OG000'}, {'value': '47.3', 'spread': 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Placebo administered as double blind, double dummy via Spiriva HandiHaler®.'}, {'id': 'OG001', 'title': 'Spiriva Handihaler®', 'description': 'Active Spiriva Handihaler® and placebo (in place of Revefenacin)\n\nSpiriva Handihaler®: Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.\n\nPlacebo for Revefenacin: Placebo administered as double blind, double dummy via nebulization.'}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '42.33', 'groupId': 'OG000'}, {'value': '84.1', 'spread': '40.02', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 29', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Peak FEV1 on Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 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'102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '7.94', 'groupId': 'BG000'}, {'value': '65.1', 'spread': '8.36', 'groupId': 'BG001'}, {'value': '65.1', 'spread': '8.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking history', 'classes': [{'title': 'Current Smoker', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}]}, {'title': 'Former Smoker', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-04', 'size': 1946714, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-01T21:36', 'hasProtocol': True}, {'date': '2017-11-27', 'size': 1974678, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-11-30T01:53', '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': 207}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'dispFirstSubmitDate': '2018-09-20', 'completionDateStruct': {'date': '2017-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-22', 'studyFirstSubmitDate': '2017-03-24', 'dispFirstSubmitQcDate': '2018-09-20', 'resultsFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2017-03-24', 'dispFirstPostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-06', 'studyFirstPostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Trough FEV1 on Day 29', 'timeFrame': 'Baseline and Day 29', 'description': 'FEV1 = forced expiratory volume at one second'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29', 'timeFrame': 'Baseline and Day 29'}, {'measure': 'Change From Baseline Trough Inspiratory Capacity (IC) on Day 29', 'timeFrame': 'Baseline and Day 29'}, {'measure': 'Change From Baseline Peak FEV1 on Day 29', 'timeFrame': 'Baseline and Day 29 (0-4 hours)'}, {'measure': 'Change From Baseline Peak FVC on Day 29', 'timeFrame': 'Baseline and Day 29 (0-4 hours)'}, {'measure': 'Summary of Rescue Medication Use: Puffs Per Day', 'timeFrame': '1 Month'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic Obstructive Pulmonary Disease, COPD', 'Low Peak Inspiratory Flow Rate (PIFR)'], 'conditions': ['Chronic Obstructive Pulmonary Disease, COPD', 'Low Peak Inspiratory Flow Rate (PIFR)']}, 'referencesModule': {'references': [{'pmid': '38560416', 'type': 'DERIVED', 'citation': 'Ohar JA, Mahler DA, Davis GN, Lombardi DA, Moran EJ, Crater GD. Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow. Can Respir J. 2024 Mar 22;2024:8034923. doi: 10.1155/2024/8034923. eCollection 2024.'}, {'pmid': '32343967', 'type': 'DERIVED', 'citation': 'Barnes CN, Mahler DA, Ohar JA, Lombardi DA, Crater GD. Peak Inspiratory Flows: Defining Repeatability Limits and a Predictive Equation for Different Inhalers. Chest. 2020 Oct;158(4):1413-1419. doi: 10.1016/j.chest.2020.03.072. Epub 2020 Apr 25.'}, {'pmid': '31647854', 'type': 'DERIVED', 'citation': 'Mahler DA, Ohar JA, Barnes CN, Moran EJ, Pendyala S, Crater GD. Nebulized Versus Dry Powder Long-Acting Muscarinic Antagonist Bronchodilators in Patients With COPD and Suboptimal Peak Inspiratory Flow Rate. Chronic Obstr Pulm Dis. 2019 Oct 23;6(4):321-31. doi: 10.15326/jcopdf.6.4.2019.0137.'}]}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, double-dummy, parallel group study to compare once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler® on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate.'}, '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 with a diagnosis of COPD.\n* Subject has a current or past cigarette smoking history (or equivalent for cigar or pipe smoking history) of at least 10 pack-years.\n* Subject is willing and able to provide signed and dated written informed consent to participate prior to initiation of any study related procedures.\n\nExclusion Criteria:\n\n* Subject has a concurrent disease or condition that, in the opinion of the investigator, would interfere with continued study participation or confound the evaluation of safety and tolerability of the study drug.\n* Subject has a history of reactions or hypersensitivity to inhaled or nebulized anticholinergics.\n* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergics, including narrow-angle glaucoma, symptomatic benign prostatic hyperplasia, bladder neck obstruction, or urinary retention.'}, 'identificationModule': {'nctId': 'NCT03095456', 'briefTitle': 'Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Viatris Inc.'}, 'officialTitle': 'A Phase 3b, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study to Compare Once Daily Nebulized Revefenacin With Spiriva Once Daily Delivered Via the HandiHaler® on Lung Function in Subjects With COPD and a Low PIFR', 'orgStudyIdInfo': {'id': '0149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Revefenacin', 'description': 'Active Revefenacin and placebo (in place of Spiriva Handihaler®)', 'interventionNames': ['Drug: Revefenacin', 'Drug: Placebo for Spiriva Handihaler®']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Spiriva Handihaler®', 'description': 'Active Spiriva Handihaler® and placebo (in place of Revefenacin)', 'interventionNames': ['Combination Product: Spiriva Handihaler®', 'Drug: Placebo for Revefenacin']}], 'interventions': [{'name': 'Revefenacin', 'type': 'DRUG', 'otherNames': ['TD-4208'], 'description': 'Revefenacin administered via nebulization.', 'armGroupLabels': ['Revefenacin']}, {'name': 'Spiriva Handihaler®', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Tiotropium'], 'description': 'Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.', 'armGroupLabels': ['Spiriva Handihaler®']}, {'name': 'Placebo for Revefenacin', 'type': 'DRUG', 'description': 'Placebo administered as double blind, double dummy via nebulization.', 'armGroupLabels': ['Spiriva Handihaler®']}, {'name': 'Placebo for Spiriva Handihaler®', 'type': 'DRUG', 'description': 'Placebo administered as double blind, double dummy via Spiriva HandiHaler®.', 'armGroupLabels': ['Revefenacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research of Rock Hill', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Theravance Biopharma'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mylan Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Theravance Biopharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}