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 < 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,. CONCLUSIONS: 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.
RCT Entities:
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 < 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,. CONCLUSIONS: 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.