Volume 6 Supplement 2
Non-inferiority efficacy comparison of mometasone furoate/formoterol versus fluticasone propionate/salmeterol combination therapies in subjects with persistent asthma
© Bernstein et al; licensee BioMed Central Ltd. 2010
Published: 22 December 2010
Mometasone furoate/formoterol (MF/F) combination therapy is a new treatment for persistent asthma. We report findings from a non-inferiority study that compared effects of MF/F and fluticasone propionate/salmeterol (FP/S) combination therapies on pulmonary function and onset of action in subjects with persistent asthma.
Materials and methods
This randomized, active-controlled, multicenter, non-inferiority trial enrolled subjects (≥12 yrs) previously treated with medium-dose inhaled corticosteroid alone or combined with a long-acting β2-agonist. Following a 2-4 wk run-in treatment period with MF administered via metered-dose inhaler (MDI) 200 μg twice daily (BID), eligible subjects were randomized to MF/F-MDI 200/10 μg BID or FP/S administered via dry-powder inhaler (DPI) 250/50 μg BID for 12 wks. The primary endpoint was change from baseline in area under the curve in forced expiratory volume in 1 s 0-12 h postdose (FEV1AUC0-12 h). Key secondary endpoints included onset of action, defined as change from baseline in FEV1 at 5 min postdose on Day 1.
This non-inferiority trial demonstrated that MDI-administered MF/F 200/10 μg BID was non-inferior to DPI-administered FP/S 250/50 μg BID in FEV1AUC0-12 h. MF/F-MDI was superior to FP/S-DPI in onset of action.
This article is published under license to BioMed Central Ltd.