A32-14 Budesonide/Glycopyrrolate/Formoterol Fumarate Effects on Lung Function and Exacerbations by Baseline Demographics in Inadequately Controlled Asthma

Abstract Rationale KALOS and LOGOS, twin Phase 3, double-blind, double-dummy, randomized studies, compared fixed-dose triple combination inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA)/long-acting muscarinic antagonist (LAMA) (budesonide/glycopyrrolate/formoterol fumarate), delivered via a metered-dose inhaler (MDI) using Aerosphere™ co-suspension delivery technology (BGF), with ICS/LABA (budesonide/formoterol fumarate), either as the standard suspension formulation (Symbicort®; BFFS) or using Aerosphere™ co-suspension delivery technology (BFFA). KALOS and LOGOS demonstrated the superiority of BGF 36 (320/36/9.6 µg) for improving lung function and exacerbation rates versus combined comparator groups BFFA and BFFS (BFFCombined) in participants with inadequately controlled asthma. This pre-specified exploratory analysis evaluated the effect of BGF 36 versus BFFCombined on lung function and exacerbations, assessed by baseline demographics, in pooled KALOS and LOGOS. Methods Participants (≥12 y) with inadequately-controlled asthma despite ICS/LABA use were randomized (pooled N = 4311) to BGF 36, BGF 18 (320/18/9.6 µg), BFFA (320/9.6 µg), or BFFS (320/9 µg) twice daily for 24 to 52 weeks. Pooled analyses across studies evaluated change from baseline in morning pre-dose trough FEV1 and FEV1 AUC0-3 over 24 weeks and severe asthma exacerbation rates, assessed by age, sex and race. Results Overall, BGF 36 showed improvements in lung function and exacerbations over 24 weeks versus BFFCombined (Table). Directionally consistent improvements in lung function were observed with BGF 36 versus BFFCombined for morning pre-dose trough FEV1 (difference in least squares means [95% confidence interval]) regardless of age (≥12-<18: 55 [−58, 169]; ≥18-<65: 68 [46, 90]; ≥65: 111 [71, 151]), sex (female: 53 [29, 77]; male: 112 [81, 143]) or race (Asian: 108 [74, 142]; Black/African American: 49 [−48, 146]; White: 53 (27, 78); American/Indian/Alaskan Native/Native Hawaiian/Other: 113 [51, 174]; Table); similar results were observed for FEV1 AUC0-3 (Table). Importantly, BGF 36 numerically reduced severe exacerbation rate compared with BFFCombined regardless of age, sex and race, except for the Black/African American subgroup, which includes a limited number of participants and has a wide confidence interval (Table). Conclusions Overall, the benefits of BGF 36 over combined ICS/LABA on lung function and exacerbations in patients with asthma are directionally consistent across different age groups, sexes, and races, highlighting that the benefits of BGF 36 are shown in a broad population irrespective of age, sex, and race. This abstract is funded by: AstraZeneca