The novel bronchodilator navafenterol: A Phase 2a, multi-centre, randomised, double-blind, placebo-controlled crossover trial in COPD

This Phase 2a, multicenter, randomized, double-blind, placebo-controlled, three-way crossover study examined the efficacy, pharmacokinetics, and safety of navafenterol versus placebo and umeclidinium/vilanterol in 73 patients with moderate-to-severe COPD. The primary endpoint was the change from baseline in trough FEV1 at Day 15; secondary endpoints included FEV1 AUC, change from baseline in trough FEV1 on Days 2 and 8, change from baseline in peak FEV1, and change from baseline in questionnaire scores (ie BCSS, CAT). Objective cough count was an exploratory endpoint of the study and was measured on Days 1 and 14 using the Vitalograph VitaloJAK cough monitor.