Efficacy and safety of indacaterol acetate on ICS background therapy in asthma

Introduction QMF149 is an investigational inhaled fixed-dose combination of indacaterol acetate (IND, long acting β2-agonist) and mometasone furoate (MF, inhaled corticosteroid) delivered via the Breezhaler® device for once daily maintenance treatment of asthma and COPD. In this study we assessed the effects of indacaterol acetate 150 µg (IND150) and 75 µg (IND75) compared with placebo (PBO). Methods In this double-blind, placebo-controlled study, 335 asthma patients aged 18 to 75 years were randomised to one of the three treatment groups (IND150, IND75, PBO) once daily for 12 weeks. All patients received MF 200 µg once daily as a background therapy throughout the study. Primary endpoint was trough FEV1 (tFEV1) at Week 12. Results At Week 12, a statistically significant improvement in tFEV1 was achieved for IND150 (106 mL; p<0.002) and IND75 (80 mL; p<0.019) compared with PBO. On Day 2, IND150 was statistically superior to IND75 (67 mL; p=0.018) in tFEV1, and IND150 was consistently numerically better than IND75 at all other timepoints over 12 weeks. IND150 and IND75 demonstrated an improvement in Asthma Control Questionnaire (ACQ)-5 with reduction of ≥0.5 at all timepoints compared with baseline (clinically meaningful). There was a positive trend for IND150 and IND75 in rescue use and peak expiratory flow rate vs PBO with a numerical benefit of IND150 over IND75. Study treatments were well tolerated with low incidence of adverse events in all groups (IND150: 28%, IND75: 36%, PBO: 39%). Conclusion IND150 and IND75 resulted in statistically significant improvements vs PBO in tFEV1 at Week 12 (Primary endpoint). Furthermore IND150 demonstrated greater effects than IND75 on lung function and rescue use.