Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function

Abstract

This study evaluated the effect of mometasone furoate/formoterol (MF/F) versus its monocomponents, each administered via metered-dose inhaler, on asthma deteriorations and lung function.

This 26-week, multicentre, double-blind, placebo-controlled study included subjects aged ≥12 years with asthma not well controlled on low-dose inhaled corticosteroids. After a 2–3-week open-label run-in (MF 100 μg twice-daily [b.i.d.]), 746 subjects were randomised to receive MF/F 100/10 μg, MF 100 μg, F 10 μg, or placebo b.i.d. Coprimary endpoints were time-to-first asthma deterioration (MF/F versus F to assess MF's effect) and change in FEV1 AUC0–12h (baseline−week 12; MF/F versus MF to assess F's effect).

The therapeutic effect of MF in the combination was demonstrated by a reduction in asthma deterioration incidence with MF/F versus F and a delayed time-to-first asthma deterioration (p<0.001). Asthma deterioration incidence was also reduced with MF/F versus MF (p=0.006). The therapeutic effect of F in the combination was demonstrated by MF/F versus MF in FEV1 AUC0–12h change (4.00 vs 2.53 L×h, respectively; p=0.001). MF/F treatment also resulted in a marked improvement in health-related quality of life.

MF/F 100/10 μg b.i.d. treatment showed greater clinical efficacy than its individual components or placebo; both components contributed to the efficacy of MF/F.