EFFICACY OF INDACATEROL/GLYCOPYRRONIUM (IND/GLY) VERSUS SALMETEROL/FLUTICASONE (SFC) ON EXACERBATIONS AND HEALTH STATUS IN GOLD GROUP D COPD PATIENTS: THE FLAME STUDY

Introduction According to current GOLD strategy combined COPD assessment, patients with severe to very severe COPD, high risk of exacerbations and more symptoms are categorised into GOLD Group D. They are recommended LABA/ICS and/or LAMA as first choice therapy. The FLAME study evaluated the rate of exacerbations with a LABA/LAMA, IND/GLY 110/50 µg o.d. vs a LABA/ICS, SFC 50/500 µg b.i.d. in COPD patients with a risk of exacerbation. Methods This 52-week, multicentre, double-blind study randomised (1:1) moderate to very severe COPD patients with history of ≥1 moderate-severe COPD exacerbation in prior year, to IND/GLY and SFC. Here, we evaluated reduction in rate of all (mild/moderate/severe) and moderate or severe exacerbations, and improvement in health status using SGRQ-C total score in GOLD Group D patients. Results Of 3362 randomised patients, 74.8% were GOLD Group D. There was a significant reduction in rate of exacerbations with IND/GLY vs SFC. IND/GLY showed statistically significant improvement in SGRQ-C total score vs SFC from Week 12 onwards. Also, higher proportion of patients with IND/GLY showed a clinically meaningful improvement in SGRQ-C total score vs SFC (odds ratio:1.32, p=0.002). Conclusion IND/GLY showed superior efficacy than SFC in reducing the rate of COPD exacerbations and improving the health status in GOLD Group D COPD patients.