OBJECTIVES: The main treatment goals of COPD management are to reduce symptoms and future risk of exacerbations. Symptoms and exacerbations create a substantial burden to patients and the healthcare system, with direct medical costs projected at $40 billion per year. These data summarize the effect of ensifentrine on COPD-related healthcare resource utilization (HRU) from pooled results of two pivotal phase 3 trials in patients with moderate to severe COPD.

METHODS: Two Phase 3, 24-week, multicenter, randomized, double-blind, placebo-controlled trials conducted September 2020 to December 2022 (the ENHANCE program) evaluated nebulized ensifentrine 3 mg twice daily in patients aged 40-80 years with symptomatic, moderate to severe COPD. The primary endpoint was change from baseline to Week 12 in average FEV₁ AUC_0-12h. HRU related to COPD over 24 weeks was evaluated as a pre-specified endpoint and included all COPD-related unscheduled visits to a physician office, visits to emergency department, and unplanned hospitalizations. A total of 1549 patients (ensifentrine, n=975; placebo, n=574) were randomized and treated in both trials.

RESULTS: At 24 weeks, fewer patients who received ensifentrine had overall COPD-related HRU compared to those who received placebo (10.1% vs 15.7%). Specifically, fewer patients who received ensifentrine experienced unscheduled COPD-related physician’s office visits (7.6% vs 12.9%), emergency room attendance (1.1% vs 1.6%), and emergency room attendance resulting in hospital admission (1.3% vs 2.3%) than those who received placebo. Correspondingly, there was a 41% reduction in rate of moderate to severe exacerbations over 24 weeks in patients who received ensifentrine vs placebo (rate ratio 0.59 [95% CI, 0.44-0.81; P<0.001).

CONCLUSIONS: Over 24 weeks, COPD-related HRU was reduced with ensifentrine treatment vs placebo, which is consistent with the exacerbation rate reduction effect also seen with ensifentrine treatment.