NCT05165485

Phase 4 COPD and Suboptimal Inspiratory Flow Rate

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®)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Theravance Biopharma · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Revefenacin	Revefenacin 175 mcg administered once daily for 84 days via nebulization
DRUG	Tiotropium	Tiotropium 18 mcg administered once daily for 84 days via Spiriva HandiHaler®
DRUG	Revefenacin Placebo	Placebo for Revefenacin administered once daily for 84 days via nebulization
DRUG	Tiotropium Placebo	Placebo for Tiotropium administered once daily for 84 days via Spiriva HandiHaler®

Timeline

• Start date: 2022-01-07
• Primary completion: 2023-11-13
• Completion: 2023-11-20
• First posted: 2021-12-21
• Last updated: 2024-12-20
• Results posted: 2024-12-20

Locations

76 sites across 1 country: United States

Regulatory

• FDA-regulated drug study