Chinese subgroup results from a study comparing single-inhaler triple therapy with dual therapy in COPD

Rationale: The FULFIL study was a global, phase IIIa, randomised, double-blind, double-dummy, parallel-group, multicentre study, which evaluated the efficacy and safety of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25µg combination inhalation powder versus twice-daily budesonide/formoterol (BUD/FOR) 400/12µg in COPD patients. 1811 patients were randomised from 15 countries, including 61 from China. The overall data demonstrated the superiority of FF/UMEC/VI versus BUD/FOR in lung function and SGRQ with comparable safety. A pre-defined subgroup analysis was conducted in Chinese COPD patients. Methods: The co-primary endpoints were the changes from baseline in trough FEV 1 and SGRQ score at 24 weeks. Analyses of endpoints included a treatment by region (China vs Not China) interaction term to allow treatment effects in Chinese patients to be estimated. Results: 61 Chinese patients were randomised (FF/UMEC/VI, n=32; BUD/FOR, n=29). At Week 24, a clinically meaningful improvement in trough FEV 1 was observed with FF/UMEC/VI vs BUD/FOR (difference 195mL; 95% CI 67, 323; p=0.003). Additionally, FF/UMEC/VI demonstrated a clinically meaningful improvement in SGRQ total score compared with BUD/FOR of -5.3 units (95% CI -12.3, 1.7; p=0.140). The overall adverse event incidence was comparable (12 [37.5%] vs 9 [31.0%] for FF/UMEC/VI and BUD/FOR, respectively). Conclusions: In this Chinese subpopulation, FF/UMEC/VI demonstrated compelling efficacy compared with an established ICS/LABA on trough FEV 1 and SGRQ, which is in keeping with the overall study findings. No new safety signals were observed. Funding: GSK (CTT116853)