Abstract Aims and objectives Clinical benefits of single-inhaler ICS/LAMA/LABA triple therapy (TT) data in patients with mild-to-moderate COPD is scarce. To investigate the effectiveness and tolerability of TT compared with LAMA/LABA dual-therapy (DT) on lung function and health-related quality of life (HR-QOL) in patients with mild-to-moderate COPD in Japan. Methods This multicentre, randomised controlled trial enrolled symptomatic patients aged 40 years with CAT score ≥7 and post-bronchodilator FEV1 50% predicted. Patients were recruited from 44 hospitals in Japan and randomised (1:1) to receive either TT (FF/UMEC/VI) or DT (UMEC/VI) for 24 weeks. The primary endpoint was the change in trough FEV1 at 12 weeks. The key secondary endpoint was the CAT responder rates (≥2-points improvement) at 24 weeks. Results Between March 2022 and September 2024, 572 patients were randomised to TT (n = 279) or DT groups (n = 278). At week 12, the mean change in trough FEV1 was 151 mL (95% confidence interval CI 129 -173 ml) in the TT and 148 mL (95% CI 130-167 ml) in the DT (p = 0.67). Among patients with baseline blood eosinophil counts 300 cells/μL, FEV1 improvements were significantly greater with TT than DT (178 vs 105 mL; p 0.05), despite similar baseline FEV1. At week 24, the rate of CAT responder was significantly higher in the TT group (n = 159, 62.6%) compared with the DT group (n = 139, 54.1%; p 0.05). Both treatments were well tolerated. Conclusions HR-QOL of patients with mild-to-moderate COPD in Japan was significantly improved when patients received TT compared to DT. Additionally, TT better improved FEV1 in those patients with eosinophilia at baseline. This abstract is funded by: GlaxoSmithKline
Takahashi et al. (Fri,) studied this question.