Efficacy and Safety of Ensifentrine in Chinese Participants With COPD: The ENHANCE-CHINA Randomized Clinical Trial.

However, efficacy and safety data on its use in Chinese participants with COPD remain limited.

然而，关于其在中国COPD患者中使用的效果和安全性的数据仍然有限。

research_question

Is nebulized ensifentrine effective and safe compared with placebo for the treatment of COPD in Chinese participants?

吸入用恩西地特在中国慢性阻塞性肺疾病患者中与安慰剂相比是否有效且安全？

study_design_and_methods

A phase III, multicenter, randomized, double-anonymized, placebo-controlledtrial was conducted between March 2023 and March 2025.

该研究为一项III期、多中心、随机、双盲、安慰剂对照试验，研究时间从2023年3月持续至2025年3月。

The study enrolled participants with moderate to severe symptomatic COPD randomized to the ensifentrine group or the placebo group (5:3) over 24 weeks.

该研究招募了中度至重度症状性慢性阻塞性肺疾病（COPD）患者，随机分为吸入ensifentrine组或安慰剂组（5:3），持续24周。

Participants were stratified according to maintenance therapy and smoking status.

根据维持治疗和吸烟状况对参与者进行了分层。

The primary end point was lung function improvement measured by FEV1 area under the curve at 0 to 12 hours.

主要终点是通过0至12小时的FEV1曲线下面积来衡量的肺功能改善。

Other end points included quality of life, symptoms, and exacerbations.

其他终点包括生活质量、症状和加重情况。

Results

Overall, 525 participants were included in the analysis, with 45.9% receiving concomitant maintenance therapy.

总体而言，分析共纳入了525名参与者，其中45.9%接受了联合维持治疗。

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).

与安慰剂相比，Ensifentrine显著改善了0至12小时的平均FEV1曲线下面积（110毫升；95%置信区间，69-151毫升；P < .0001）。

Lung function improvement was consistent across clinically relevant subgroups, including participants with and without maintenance therapy, as well as participants with moderate and severe COPD.

肺功能改善在包括接受和未接受维持治疗的参与者，以及中度和重度COPD患者在内的临床相关亚组中是一致的。

Ensifentrine significantly improved Transition Dyspnea Index score and showed improvements in Evaluating Respiratory Symptoms and St. George's Respiratory Questionnaire scores vs placebo.

恩西布兰显著改善了呼吸困难指数评分，并在与安慰剂相比时，在评估呼吸症状和圣乔治呼吸问卷评分方面显示出改善。

Ensifentrine treatment tended to reduce the rate of moderate to severe exacerbations and increased the time to first exacerbation.

Ensifentrine治疗倾向于降低中度至重度急性加重的比率，并增加了首次急性加重发生的时间。

Adverse eventrates were similar between the ensifentrine and placebo groups.

Ensifentrine组和安慰剂组之间的不良事件发生率相似。

interpretation

Ensifentrine was shown to significantly improve lung function and showed efficacy benefits in symptoms and quality of life improvement in Chinese individuals with COPD.

研究显示，恩西特林能显著改善肺功能，并在改善中国慢性阻塞性肺疾病患者的症状和生活质量方面显示出疗效优势。

clinical_trial_registration

ClinicalTrials.gov; No.: NCT05743075; URL: www.

ClinicalTrials.gov; 注册号：NCT05743075; 网址：www。

clinicaltrials

gov.

5年总生存率为75%，95%置信区间为70-80%。