At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Study Comparing Improvements in Lung Function in Adults With Severe to Very Severe Chronic Obstructive Pulmonary Disease and Suboptimal Inspiratory Flow Rate Following Once-Daily Treatment Over 12 Weeks With Either Revefenacin Inhalation Solution Delivered Via Standard Jet Nebulizer or Tiotropium Delivered Via a Dry Powder Inhaler (Spiriva® HandiHaler®)
In Brief
A Phase 4 clinical trial evaluating Revefenacin, Tiotropium, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 404 participants across 76 sites.
Detailed Summary
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 Details
Timeline
Interventions
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
Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®