Abstract
Methods A 2–3-week run-in period with twice daily (BID) MF100μg, MF-200μg, or MF-400μg was performed before subject (≥12y) randomization to BID: MF/F-100/10μg, MF100μg, 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.
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