Relationship between baseline rescue medication use and reductions in COPD exacerbation rates: a subgroup analysis of the ETHOS trial

Abstract

<b>Background:</b> Budesonide/glycopyrronium/formoterol (BGF) triple therapy reduced exacerbation rates vs dual therapies in patients with moderate-to-very severe COPD in the ETHOS trial (NCT02465567). <b>Aim:</b> To assess the relationship between baseline rescue medication use and benefits of triple therapy on exacerbations in ETHOS. <b>Methods:</b> Patients with a postbronchodilator FEV₁ 25–65% of predicted, CAT score ≥10 on ≥2 inhaled maintenance therapies, and ≥1 moderate/severe exacerbation in the prior year were randomized to BGF (320/14.4/10µg or 160/14.4/10µg), glycopyrronium/formoterol 14.4/10µg or budesonide/formoterol 320/10µg twice-daily for 52 weeks. Treatments were administered via a single metered dose Aerosphere inhaler. Exacerbation rates were analyzed post-hoc according to baseline SABA rescue medication use (mean puffs/day: ≤4, n=5912; &gt;4, n=2564). <b>Results:</b> Across treatment groups, moderate/severe exacerbations rates were higher in patients using &gt;4 puffs/day of SABA (Table). Benefits of BGF 320 on exacerbation rates vs dual therapies were seen in both subgroups but were greater in those with &gt;4 puffs/day of SABA. <b>Conclusion:</b> Triple therapy with BGF 320 reduced COPD exacerbations vs dual therapies in both subgroups, but high baseline rescue medication use may identify patients at greater risk of moderate/severe exacerbations, who may derive even greater benefit from triple therapy.