Date Published: November 14, 2011
Publisher: BioMed Central
Author(s): SF Weinstein, RA Nathan, EO Meltzer, D Gates, H Nolte.
We present a post hoc analysis from 3 phase III clinical trials examining the effects of mometasone furoate/ formoterol (MF/F) combination therapy on asthma deterioration (ie, severe asthma exacerbation) in subjects previously uncontrolled on low-, medium-, or high-dose inhaled corticosteroids (ICS).
A 2–3-week run-in period with twice daily (BID) MF-100µg, MF-200µg, or MF-400µg was performed before subject (≥12y) randomization to BID: MF/F-100/10µg, MF-100µg, F-10µg, or placebo for 26weeks (n=746); MF/F-200/10mg, MF-200µg, F-10µg, or placebo for 26weeks (n=781); MF/F-200/10µg, MF/F-400/10µg, or MF-400µg for 12weeks (n=728 ). Assessment of asthma deterioration (ie, 20% decrease in forced expiratory volume in 1s [FEV1]; 30% decrease in peak expiratory flow [PEF] on ≥2 consecutive days; or clinically judged deterioration [ie, emergency treatment, hospitalization, or treatment with excluded medications]) was a co-primary endpoint for studies, and a secondary endpoint for study. Post hoc pair-wise comparisons of pooled MF/F vs MF, F, and placebo treatment groups were performed.
Sample sizes in this pooled analysis were: MF/F, n=861; MF, n=620; F, n=390; placebo, n=384. There was a significantly lower incidence of asthma deterioration with MF/F= 17.2% vs MF=26.1% (P=.002), F=49.5% (P<.001), and placebo550.8% (P<.001). Incidence rates for asthma deterioration subtypes were: FEV1 reduction: MF/F=7.0%, MF=10.0%, F=13.8%, placebo=17.7%; PEF reduction: MF/F=7.5%, MF=12.6%, F=27.2%, placebo=26.3%; clinically judged deterioration: MF/F=2.1%, MF=2.6%, F=6.7%, placebo=5.2%. MF/F-treated subjects experienced a significantly lower rate of asthma deterioration compared with MF, F, and placebo in subjects previously uncontrolled on low-, medium-, or high-dose ICS in this pooled analysis. Source: http://doi.org/10.1186/1710-1492-7-S2-A13