Revefenacin Peak Inspiratory Flow Rate (PIFR) Study in COPD
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|ClinicalTrials.gov Identifier: NCT03095456|
Recruitment Status : Completed
First Posted : March 29, 2017
Results First Posted : December 31, 2018
Last Update Posted : May 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease, COPD Low Peak Inspiratory Flow Rate (PIFR)||Drug: Revefenacin Combination Product: Spiriva Handihaler® Drug: Placebo for Revefenacin Drug: Placebo for Spiriva Handihaler®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||March 27, 2017|
|Actual Primary Completion Date :||November 25, 2017|
|Actual Study Completion Date :||November 25, 2017|
Active Revefenacin and placebo (in place of Spiriva Handihaler®)
Revefenacin administered via nebulization.
Other Name: TD-4208
Drug: Placebo for Spiriva Handihaler®
Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
Active Comparator: Spiriva Handihaler®
Active Spiriva Handihaler® and placebo (in place of Revefenacin)
Combination Product: Spiriva Handihaler®
Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
Other Name: Tiotropium
Drug: Placebo for Revefenacin
Placebo administered as double blind, double dummy via nebulization.
- Change From Baseline in Trough FEV1 on Day 29 [ Time Frame: Baseline and Day 29 ]FEV1 = forced expiratory volume at one second
- Change From Baseline Trough FVC (Forced Vital Capacity) on Day 29 [ Time Frame: Baseline and Day 29 ]
- Change From Baseline Trough Inspiratory Capacity (IC) on Day 29 [ Time Frame: Baseline and Day 29 ]
- Change From Baseline Peak FEV1 on Day 29 [ Time Frame: Baseline and Day 29 (0-4 hours) ]
- Change From Baseline Peak FVC on Day 29 [ Time Frame: Baseline and Day 29 (0-4 hours) ]
- Summary of Rescue Medication Use: Puffs Per Day [ Time Frame: 1 Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095456
|United States, South Carolina|
|Clinical Research of Rock Hill|
|Rock Hill, South Carolina, United States, 29732|
|Study Director:||Medical Monitor||Theravance Biopharma|