Efficacy and Safety of Ensifentrine in Chinese Participants With COPD

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: area under the curve at 0 to 12 hours. Other end points included quality of life, symptoms, and exacerbations. RESULTS: 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.