In the Phase III ETHOS study (NCT02465567), budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) triple therapy at two inhaled corticosteroid (ICS) doses reduced moderate/severe exacerbation rates and improved symptoms, HRQoL, and lung function in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). For a study, researchers sought to determine if the advantage of BGF over GFF was due to patients receiving ICS before being assigned to GFF.
ETHOS was a 52-week, randomized, double-blind, multicenter, parallel-group trial in symptomatic COPD patients who had experienced at least ≥1 moderate or severe exacerbation in the preceding year. Using a single metered dosage Aerosphere™ inhaler, patients were given BGF 320/14.4/10 μg, BGF 160/14.4/10 μg, GFF 14.4/10 μg, or BFF 320/10 g twice a day. Efficacy and safety were investigated in patients with and without prior ICS usage in the 30 days prior to screening in these subgroup studies.
About 8,509 patients were included in the modified intent-to-treat group (previous ICS usage, n = 6,810 [80%]; no prior ICS use, n = 1,699 [20%]). BGF 320 compared to GFF decreased moderate/severe exacerbation rates by 24% and 23% in individuals with and without prior ICS usage, respectively. The benefits of BGF 320 against GFF were similar in terms of exacerbations, symptoms, HRQoL, lung function, and safety. BGF 160 and GFF showed comparable trends. Exacerbations, symptoms, HRQoL, and lung function were all improved with BGF versus GFF, regardless of prior ICS treatment in the 30 days before screening.