Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function.
Author(s): Meltzer EO, Kuna P, Nolte H, S Nayak A, Laforce C
Affiliation(s): San Diego, CA, USA.
Publication date & source: 2011-08-04, Eur Respir J., [Epub ahead of print]
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 mug twice-daily [b.i.d.]), 746 subjects were randomised to receive MF/F 100/10 mug, MF 100 mug, F 10 mug, 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 Lxh, respectively; p=0.001). MF/F treatment also resulted in a marked improvement in health-related quality of life. MF/F 100/10 mug b.i.d. treatment showed greater clinical efficacy than its individual components or placebo; both components contributed to the efficacy of MF/F.
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