Chest · 2026
Efficacy and Safety of Ensifentrine in Chinese Participants With COPD: The ENHANCE-CHINA Randomized Clinical Trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Zhou Yumin, Chen Charlie, Wang Zihui, Wu Fan, Tian Dongbo, Xiao Zuke, Cao Jie, Xu Feng, Gao Junzhen, Chen Juan, Peng Liping, Dai Yuanrong, Dong Limin, Hu Yi, Yang Ting, Liu Chuntao, Wang Limin, Liu Xiao, Yang Tiebo, Yang Guoru, Zhu Dan, Wei Zonghui, Gu Wei, Ran Pixin, Zhong Nanshan, ENHANCE-CHINA Investigators
Аннотация
BACKGROUND: Ensifentrine, a novel phosphodiesterase 3/4 inhibitor, was shown to significantly improve lung function and reduced COPD exacerbations in previous trials in Western populations. However, efficacy and safety data on its use in Chinese participants with COPD remain limited.
RESEARCH QUESTION: Is nebulized ensifentrine effective and safe compared with placebo for the treatment of COPD in Chinese participants?
STUDY DESIGN AND METHODS: A phase III, multicenter, randomized, double-anonymized, placebo-controlled trial was conducted between March 2023 and March 2025. The study enrolled participants with moderate to severe symptomatic COPD randomized to the ensifentrine group or the placebo group (5:3) over 24 weeks. Participants were stratified according to maintenance therapy and smoking status. The primary end point was lung function improvement measured by FEV1 area under the curve at 0 to 12 hours. Other end points included quality of life, symptoms, and exacerbations.
RESULTS: Overall, 525 participants were included in the analysis, with 45.9% receiving concomitant maintenance therapy. 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). 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. Ensifentrine significantly improved Transition Dyspnea Index score and showed improvements in Evaluating Respiratory Symptoms and St. George's Respiratory Questionnaire scores vs placebo. Ensifentrine treatment tended to reduce the rate of moderate to severe exacerbations and increased the time to first exacerbation. Adverse event rates were similar between the ensifentrine and placebo groups.
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.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT05743075; URL: www.
CLINICALTRIALS: gov.
RESEARCH QUESTION: Is nebulized ensifentrine effective and safe compared with placebo for the treatment of COPD in Chinese participants?
STUDY DESIGN AND METHODS: A phase III, multicenter, randomized, double-anonymized, placebo-controlled trial was conducted between March 2023 and March 2025. The study enrolled participants with moderate to severe symptomatic COPD randomized to the ensifentrine group or the placebo group (5:3) over 24 weeks. Participants were stratified according to maintenance therapy and smoking status. The primary end point was lung function improvement measured by FEV1 area under the curve at 0 to 12 hours. Other end points included quality of life, symptoms, and exacerbations.
RESULTS: Overall, 525 participants were included in the analysis, with 45.9% receiving concomitant maintenance therapy. 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). 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. Ensifentrine significantly improved Transition Dyspnea Index score and showed improvements in Evaluating Respiratory Symptoms and St. George's Respiratory Questionnaire scores vs placebo. Ensifentrine treatment tended to reduce the rate of moderate to severe exacerbations and increased the time to first exacerbation. Adverse event rates were similar between the ensifentrine and placebo groups.
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.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT05743075; URL: www.
CLINICALTRIALS: gov.