Two randomized, Phase IIIb, double-blind, multicenter, crossover studies were conducted to evaluate the 24-hour lung function profile of BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate) 18 mcg/9.6 mcg twice daily compared with placebo twice daily in patients with moderate to very severe COPD after 4 weeks of chronic dosing (Study A and Study B). Study B also included an open-label active control.1
The primary endpoint was the change in FEV1 AUC0-24 on Day 29 from baseline for BEVESPI AEROSPHERE twice daily compared with placebo twice daily. Secondary endpoints included peak change from baseline in FEV1 and inspiratory capacity following the evening dose on Day 29.1
Inclusion criteria: a clinical diagnosis of COPD, 40 to 80 years of age, a history of smoking ≥10 pack-years, a post-albuterol FEV1 <80% of predicted normal values, and a ratio of FEV1/FVC of <0.70.2
In Study A, of the 35 subjects included in the efficacy analysis for BEVESPI AEROSPHERE, the majority were male (57%) and Caucasian (77%), with a mean age of 61 years and an average smoking history of 49 pack-years (57% current smokers). During screening, mean postbronchodilator percent predicted FEV1 was 53% (range: 19% to 79%).2
In Study B, of the 75 subjects included in the efficacy analysis, the majority were female (64%) and Caucasian (91%), with a mean age of 62 years and an average smoking history of 56 pack-years (63% current smokers). During screening, mean postbronchodilator percent predicted FEV1 was 57% (range: 31% to 80%).2
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References: 1. Reisner C, Gottschlich G, Fakih F, et al. Respir Res. 2017;18:157. 2. Data on File, REF-4976, AZPLP.