RCT Abstract - Budesonide/glycopyrronium/formoterol fumarate dihydrate triple therapy for inadequately-controlled asthma: KALOS and LOGOS study results

A long-acting muscarinic antagonist (LAMA) may be added to medium-/high-dose inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA) therapy in patients with uncontrolled asthma. KALOS and LOGOS, two Phase 3, double-blind, double-dummy randomised studies, compared fixed-dose triple combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) with budesonide/formoterol fumarate dihydrate via metered-dose inhaler (MDI; BFF) and via pressurised MDI ([Symbicort®] BUD/FORM). Participants (≥12 y) with inadequately-controlled asthma despite ICS/LABA use were randomised (pooled N=4311) to BGF 320/28.8/10 µg, BGF 320/14.4/10 µg, BFF 320/10 µg or BUD/FORM 320/9 µg (BID) for 24 to 52 weeks. Key lung function endpoints included change from baseline in morning pre-dose trough FEV1 and FEV1 AUC0–3 over 24 weeks; Day 1 onset of action was also assessed. Pooled analyses across studies assessed severe exacerbation rate. Safety measures included AE monitoring. BGF 320/28.8/10 µg improved lung function endpoints in each study, and in the pooled analysis BGF 320/28.8/10 µg reduced severe exacerbation rate vs combined ICS/LABA comparator arms (BFF+BUD/FORM; see Table for European regulatory approach). AE frequency was comparable across treatments in each study. BGF 320/28.8/10 µg is superior to dual ICS/LABA in adults and adolescents with asthma inadequately-controlled by ICS/LABA. erj;66/suppl_69/RCT1115/F1 F1 F1