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A long-acting muscarinic antagonist (LAMA) may be added to medium-/high-dose inhaled corticosteroid (ICS)/long-acting β 2-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 1 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.Abstract P297 Table 1Summary of primary and secondary efficacy endpoint results (European regulatory approach)