Phase 4 COPD and Suboptimal Inspiratory Flow Rate

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.

Timeline

Start

2022-01-07

Primary completion

2023-11-13

Completion

2023-11-20

Outcome

Missed primary endpoint

registry analysis (superiority test); Tiotropium vs Revefenacin; p = 0.22; Mean Difference (Net) -23 (95% CI -61 to 14) NCT05165485 ↗

release “While the primary endpoint in the Phase 4 PIFR-2 study was not met” theravance.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Revefenacin	Small molecule	175 ug	Other
Subject	Tiotropium	Other / unclassified	18 ug	Inhaled

Indications