Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• Lung Function Improvement: Ensifentrine significantly improved lung function, measured by FEV(1) AUC (0-12 hours), with an 87 ml improvement (95% CI (Confidence Interval), 55, 119) in ENHANCE-1 and a 94 ml improvement (95% CI, 65, 124) in ENHANCE-2, both with P < 0.001 compared to placebo.
• Exacerbation Reduction: Ensifentrine reduced the rate of moderate or severe exacerbations versus placebo over 24 weeks, with a rate ratio of 0.64 (95% CI, 0.40, 1.00; P = 0.050) in ENHANCE-1 and 0.57 (95% CI, 0.38, 0.87; P = 0.009) in ENHANCE-2. It also increased the time to the first exacerbation, with a hazard ratio of 0.62 (95% CI, 0.39, 0.97; P = 0.038) in ENHANCE-1 and 0.58 (95% CI, 0.38, 0.87; P = 0.009) in ENHANCE-2.
• Quality of Life and Symptoms: Ensifentrine improved quality of life (SGRQ) and symptoms (E-RS) at Week 24 in ENHANCE-1, but no significant improvements were observed in ENHANCE-2 for these outcomes.
• The safety outcomes for ensifentrine demonstrated that adverse event rates were similar between the ensifentrine and placebo groups in both ENHANCE-1 and ENHANCE-2 trials.
• No significant safety concerns or adverse effects were reported, and there were no notable safety differences among the various population types or subgroups examined in the study.