Study is a randomized, double-blind, double-dummy, parallel-group study evaluating efficacy and safety of revefenacin vs. tiotropium in adults with severe to very severe COPD and suboptimal PIFR.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
404
Revefenacin 175 mcg administered once daily for 84 days via nebulization
Tiotropium 18 mcg administered once daily for 84 days via Spiriva HandiHaler®
Placebo for Revefenacin administered once daily for 84 days via nebulization
FEV1
Change from baseline in forced expiratory volume in one second (FEV1) at trough on Day 85
Time frame: Baseline, Day 85 following 84 days of dosing
OTE on FEV1
Trough Overall Treatment Effect (OTE) on FEV1. Overall is defined as the average change from baseline at trough across Day 30, Day 60, and Day 85.
Time frame: Baseline, Day 30, Day 60, Day 85
FEV1
Change from baseline in FEV1 at trough on Day 30
Time frame: Baseline, Day 30
FEV1
Change from baseline in FEV1 at trough on Day 60
Time frame: Baseline, Day 60
FVC
Change from baseline in forced vital capacity (FVC) at trough on Day 85
Time frame: Baseline, Day 85
80-mL Increase in FEV1 at Trough on Day 85
Participants with an 80-mL or greater change from baseline FEV1 at trough were counted as responders. Participants with change from baseline FEV1 \< 80 mL and participants with change from baseline FEV1 not obtained were counted as nonresponders.
Time frame: Baseline, Day 85
First Occurrence of CompEx Event
Count of participants experiencing events and time from first dose to first occurrence of a composite endpoint for exacerbations of COPD (CompEx) event were evaluated. The statistical analysis is a Cox proportional hazards model analysis of time to first event and the Revefenacin / Tiotropium hazard ratio is calculated and reported. Data are reported as the numbers of subjects with events and the hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table. CompEx events are a composite of moderate or severe COPD exacerbation, premature termination from the study for any reason other than Sponsor decision, and clinically relevant deterioration in COPD. Clinically relevant deterioration events are defined as increases in COPD symptoms meeting specified criteria based on participant diary data.
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Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®
Theravance Biopharma Investigational Site
Jasper, Alabama, United States
Theravance Biopharma Investigational Site
Phoenix, Arizona, United States
Theravance Biopharma Investigational Site
Tucson, Arizona, United States
Theravance Biopharma Investigational Site
Newport Beach, California, United States
Theravance Biopharma Investigational Site
San Diego, California, United States
Theravance Biopharma Investigational Site
Stockton, California, United States
Theravance Biopharma Investigational Site
Upland, California, United States
Theravance Biopharma Investigational Site
Lakewood, Colorado, United States
Theravance Biopharma Investigational Site
Brandon, Florida, United States
Theravance Biopharma Investigational Site
Clearwater, Florida, United States
...and 66 more locations
Time frame: Date of first dose through date of last dose + 7 days