Mometasone furoate (MF) improves lung function in pediatric asthma: A double-blind, randomized controlled...

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.

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.

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 < 0.001), and 5.34 (P = 0.001) percentage-points for MF-MDI 50, 100, and 200 mcg BID, respectively. The LS mean difference for MF-MDI 50 mcg BID versus MF-DPI 100 mcg QD PM was 1.39 (P = 0.368). AE incidences were similar among all treatment groups. There were no reports of oropharyngeal candidiasis or dysphonia, which were AEs pre-specified for analysis,.

In children ages 5-11 years with persistent asthma, all three doses of MF-MDI (50, 100, and 200 mcg BID) demonstrated significant improvement in FEV₁ after 12 weeks of treatment. MF was generally well tolerated with no new safety concerns identified in this trial. Pediatr Pulmonol. 2017;52:310-318. © 2016 Wiley Periodicals, Inc.