Phase 2a, randomized trial of mitiperstat versus placebo in patients with COPD at high risk of exacerbation (CRESCENDO)

This paper described the design of a Phase 2a, randomized, 24-week, double-blind study that will evaluate the efficacy and safety of mitiperstat versus placebo in patients with COPD who are at high risk of exacerbation. The primary endpoint will be the time to disease worsening, encompassing changes in symptoms, reliever use, lung function, treatment for exacerbation, and/or study dropout. A cough sub-study will be conducted in selected countries to examine the association between cough frequency and lung function, with 24-hour cough monitoring performed using the Vitalograph VitaloJAK cough monitor at Weeks 1 and 12