Mometasone furoate (MF) improves lung function in pediatric asthma: A double‐blind, randomized controlled dose‐ranging trial of MF metered‐dose inhaler

Summary Objectives Mometasone furoate (MF), delivered via dry‐powder inhaler (DPI) QD in the evening (PM), is a treatment option for pediatric patients with asthma. We evaluated MF delivered via a metered‐dose inhaler (MDI), in children ages 5–11 years with persistent asthma. Methods This was a 12‐week double‐blind, double‐dummy, placebo‐controlled trial. Pateints were randomized to the following treatments: MF‐MDI 50 mcg BID, MF‐MDI 100 mcg BID, MF‐MDI 200 mcg BID, MF‐DPI 100 mcg QD PM, and placebo. The primary analysis assessed MF‐MDI doses versus placebo, on the change in %‐predicted forced expiratory volume in one second (FEV1) from baseline to week‐12; a secondary analysis compared MF‐MDI 50 mcg BID versus MF‐DPI 100 mcg QD PM. Adverse events (AEs) were monitored throughout the trial. Results For change from baseline in %‐predicted FEV1 at week 12, least‐squares (LS) mean differences from placebo were 3.87 (P = 0.019), 6.29 (P