PT  - JOURNAL ARTICLE
AU  - Meltzer, E.O.
AU  - Kuna, P.
AU  - Nolte, H.
AU  - S. Nayak, A.
AU  - LaForce, C.
AU  - on Behalf of the P04073 Study Investigators
TI  - Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function
AID  - 10.1183/09031936.00020310
DP  - 2011 Jan 01
TA  - European Respiratory Journal
PG  - erj00203-2010
4099  - http://erj.ersjournals.com/content/early/2011/08/04/09031936.00020310.short
4100  - http://erj.ersjournals.com/content/early/2011/08/04/09031936.00020310.full
AB  - 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.