Mometasone Furoate (Mf) Improves Lung Function In Pediatric Asthma: A Dose-Ranging Study Of Mf Metered-Dose Inhaler (Mdi)

The inhaled corticosteroid MF, as delivered via dry-powder inhaler (DPI) QD in the evening (PM), is approved in the US to treat pediatric asthma. This study evaluated 3 doses of MF as delivered via MDI, in children ages 5-11yr with persistent asthma. This 12-week randomized, double-blind, placebo-controlled study included 5 arms: MF-MDI 50mcg BID, MF-MDI 100mcg BID, MF-MDI 200mcg BID, MF-DPI 100mcg QD PM and placebo, using a double-dummy design. The primary analysis assessed 3 doses of MF-MDI, vs placebo, on the change in %-predicted forced expiratory volume in one second (FEV1) from Baseline to Week-12; a secondary analysis compared MF-MDI 50mcg BID versus MF-DPI 100mcg QD PM. Adverse events (AEs) were monitored throughout the study. All 3 doses of MF-MDI were superior to placebo on %-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 200mcg BID, respectively. MF-MDI 50mcg BID was similar to MF-DPI 100mcg QD PM, though the LS mean difference of 1.39 (P=0.368) numerically favored MF-MDI 50mcg BID. 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 the trial. In children ages 5-11yr with persistent asthma, all three doses of MF-MDI (50mcg, 100mcg, and 200mcg) BID demonstrated significant improvement in FEV1 after 12 weeks of treatment. MF was generally well tolerated; no new safety concerns were identified in this trial.