A Study to Evaluate the Efficacy and Safety of Ensifentrine for 24 Weeks in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical study, which aims to evaluate the efficacy, safety, and PK characteristics of Ensifentrine 3 mg twice daily (BID) for 24 weeks treatment of moderate to severe COPD.

Timeline

Start

2023-03-10

Primary completion

2024-12-06

Completion

2025-03-07

Outcome

Met primary endpoint

paper Ensifentrine significantly improved average FEV1 area under the curve at 0 to 12 hours vs placebo (110 mL; 95% CI, 69-151 mL; P < .0001). PMID 41895581 ↗

Publications

• Zhou Y, Chen C, Wang Z, Wu F, Tian D, Xiao Z, Cao J, Xu F, Gao J, Chen J, Peng L, Dai Y, Dong L, Hu Y, Yang T, Liu C, Wang L, Liu X, Yang T, Yang G, Zhu D, Wei Z, Gu W, Ran P, Zhong N; ENHANCE-CHINA Investigators. Efficacy and Safety of Ensifentrine in Chinese Participants With COPD: The ENHANCE-CHINA Randomized Clinical Trial. Chest. 2026 Mar 25:S0012-3692(26)00414-9. doi: 10.1016/j.chest.2026.02.035. Online ahead of print.

Drugs

Indications