drugset / Trial / NCT05046795

Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD)

NCT05046795 ↗

Phase 3 Completed 258 enrolled Mylan Pharma UK Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a phase III clinical study to assess the efficacy and safety of Revefenacin inhalation solution 175 mcg administered once daily via nebulization for 12 weeks compared to placebo in a population of Chinese subjects with moderate to very severe COPD.

Timeline

Start
2021-11-10
Primary completion
2023-07-26
Completion
2023-07-26

Outcome

Met primary endpoint

registry analysis (superiority test); Revefenacin Inhalation Solution 175 mcg QD. vs Placebo Inhalation Solution QD.; p <0.0001; Mean Difference (Net) 150.91 (95% CI 104.145 to 197.671) NCT05046795 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Revefenacin Small molecule 175 ug Inhaled