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 FEV1 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 FEV1 46.51% predicted, QMF149 n = 316; SFC n = 313) were randomised. The primary objective was met. QMF149 showed significant improvement in trough FEV1 vs SFC (LSM treatment difference [LSMTD] 56mL; p < 0.001). QMF149 improved significantly TDI (LSMTD 0.5; p < 0.026) and numerically SGRQ (-1.66, p = 0.093) vs SFC. QMF149 significantly prolonged the time to first moderate or severe exacerbation with a 49% reduction in hazard ratio (hazard ratio [HR] 0.51; CI 0.298, 0.855; p = 0.011) and was associated with 44% reduction in the number of moderate or severe exacerbations (rate ratio [RR] 0.56; CI 0.331, 0.937; p = 0.028). A significantly greater percentage of days with no rescue medication (LSMTD 6.26%; p = 0.007) and significantly fewer rescue medication use was observed with QMF149 (daily number of puffs LSMTD -0.47; p = 0.003). Both treatments were well tolerated with low incidence of AEs.
Conclusion When compared with SFC, QMF149 significantly improves trough FEV1 and dyspnoea, reduces exacerbations and rescue medication use in patients with moderate to very severe COPD.