P251 Efficacy And Safety Of Once-daily Indacaterol/mometasone Compared With Twice-daily Salmeterol/fluticasone In Patients With Moderate To Very Severe Copd

Introduction QMF149 is an investigational inhaled fixed-dose combination of indacaterol acetate and mometasone furoate via the Breezhaler ® device for once daily maintenance treatment of asthma and COPD. This double-blind, 12-week study compared QMF149 (150/160μg) o.d. with salmeterol 50µg/fluticasone 500µg, (Seretide ® ; SFC) b.i.d. in patients with moderate to very severe COPD. Objectives Primary objective of the study was to demonstrate the non-inferiority of QMF149 vs SFC in terms of trough FEV 1 at Week 12. Main secondary objectives were to compare the efficacy of QMF149 vs SFC in terms of dyspnoea via Transition Dyspnoea Index (TDI), health status via St. George Respiratory Questionnaire (SGRQ), rescue medication, exacerbations and safety during the treatment period. Results 629 patients (mean FEV 1 46.51% predicted, QMF149 n = 316; SFC n = 313) were randomised. The primary objective was met. QMF149 showed significant improvement in trough FEV 1 vs SFC (LSM treatment difference [LSMTD] 56mL; p Conclusion When compared with SFC, QMF149 significantly improves trough FEV 1 and dyspnoea, reduces exacerbations and rescue medication use in patients with moderate to very severe COPD.