The clinical development program for BEVESPI AEROSPHERE included two 24-week, randomized, double-blind, placebo-controlled, parallel-group trials in subjects with moderate to very severe COPD. Both trials evaluated BEVESPI AEROSPHERE 18 mcg/9.6 mcg, glycopyrrolate 18 mcg, formoterol fumarate 9.6 mcg, and placebo administered twice daily. Trial 1 also included an open-label active control.1
The primary endpoint for Trial 1 and Trial 2 was change from baseline in trough FEV1 at Week 24 compared with placebo, glycopyrrolate 18 mcg twice daily, and formoterol fumarate 9.6 mcg twice daily. The comparison of BEVESPI AEROSPHERE with glycopyrrolate 18 mcg and formoterol fumarate 9.6 mcg was assessed to evaluate the contribution of the individual components to BEVESPI AEROSPHERE.1 Secondary endpoints included change from baseline in peak FEV1 at Week 24, time to onset of action on Day 1, and change from baseline in daily rescue albuterol use over 24 weeks.1,2
Inclusion criteria: A clinical diagnosis of COPD, between 40 to 80 years of age, a history of smoking ≥10 pack-years, a post-albuterol FEV1 of <80% of predicted normal values, and a ratio of FEV1/FVC <0.7.1,2
Of the 3699 subjects included in the 24-week trials for BEVESPI AEROSPHERE, the majority were male (56%) and Caucasian (91%), with a mean age of 63 years and an average smoking history of 51 pack-years (54% current smokers). During screening, mean postbronchodilator percent predicted FEV1 was 51% (range: 19% to 82%) and mean percent reversibility was 20% (range: -32% to 135%).1
References: 1. BEVESPI AEROSPHERE [Package Insert]. Wilmington, DE: AstraZeneca; 2016. 2. Martinez FJ et al. Chest. 2017;151(2):340-357.