Long-term efficacy of QMF149 in persistent asthma

QMF is an investigational once-daily (QD) fixed-dose combination of indacaterol (IND) and mometasone furoate (MF). The efficacy of QMF was assessed in a randomised, double-blind, multi-centre, 6–21 month, Phase II study. Patients (12–70 years) received QMF (IND maleate 500µg/MF 400µg) or MF (400µg), both QD via the Twisthaler®*. Based on systemic exposure, this QMF dose is comparable to 150µg IND/160µg MF in the Concept1 (Breezhaler®) inhalation device, the delivery device to be used in future QMF studies. The primary endpoint was time to first serious exacerbation (resulting in hospitalisation, intubation or death). Secondary endpoints included time to first exacerbation requiring systemic corticosteroids (SCS), annual rate of exacerbations requiring SCS, lung function and symptoms. 1519 patients were randomised (QMF 756, MF 763), of which 8 (QMF 2, MF 6) were hospitalised for a serious exacerbation (none required intubation or resulted in death). QMF reduced the risk of a serious exacerbation vs MF by 69% (HR=0.31; 90% CI 0.08, 1.19; p=0.076). QMF had a significant risk reduction of 30% in time to first exacerbation requiring SCS (HR=0.70; 95% CI: 0.56, 0.89; p=0.003), and significantly reduced the annual rate of exacerbations requiring SCS by 29% (RR=0.71; 95% CI: 0.55, 0.90, p=0.005) vs MF. Trough FEV 1 significantly improved with QMF vs MF at all visits (100 to 140 mL, p * Twisthaler® is a registered trademark of Schering-Plough LTD.