engleski

Mometasone furoate/formoterl reduces asthma deteriorations and improves lung function

This study evaluated the effect of mometasone furoate (MF)/formoterol (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 yrs with not well-controlled asthma on low- dose inhaled corticosteroids. After a 2-3-week open-label run-in (MF 100 μg b.i.d.), 746 subjects were randomised to receive placebo, F 10 μg, MF 100 μg or MF/F 100/10 μg b.i.d. Co-primary end- points were time to first asthma deterioration (MF/F versus F to assess effect of MF) and change in forced expiratory volume in 1 s (FEV(1)) area under the curve of serial spirometry measurements over the 12-h period following the morning dose (AUC(0-12h)) (baseline to week 12 ; MF/F versus MF to assess effect of F). 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 FEV(1) AUC(0-12h) change (4.00 versus 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.

Asthma control, asthma deteriorationasthma exacerbation, efficacy, mometasone, furoate/formoterol combinationtherapy, randomised clinical trial

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