drugset / Trial / NCT05046795
Revefenacin in Chinese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease(COPD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Revefenacin | Small molecule | 175 ug | Inhaled |