Once-Daily Mometasone Furoate Administered by Dry Powder Inhaler for the Treatment of Children with Persistent Asthma

Abstract

Inhaled corticosteroids (ICS) are recommended as the standard treatment for children with persistent asthma. However, compliance with ICS therapy can be difficult, especially with complicated dosing regimens, and few studies have investigated once-daily dosing in pediatric populations. This 12-week, randomized, double-blinded, parallel-group, multicenter trial is the first study to evaluate the efficacy and safety of mometasone furoate (MF) administered by pediatric patients once daily in the morning via a novel dry powder inhaler (MF-DPI; Twisthaler^®; Schering-Plough, Kenilworth, NJ). The study was conducted in 290 patients aged 4 to 11 years with persistent asthma of more than 6 months' duration who were currently receiving ICS therapy twice daily. Patients were randomized to once-daily treatment in the morning with MF-DPI 100 μg, MF-DPI 200 μg, or placebo. The primary efficacy variable was the change from baseline to end point (i.e., last evaluable visit) in the percent predicted forced expiratory volume in 1 second (%FEV₁). At end point, the change from baseline in %FEV₁ was significantly improved in patients receiving either MF-DPI 100 μg or MF-DPI 200 μg (5.7% and 5.0%, respectively) compared with the change observed in patients receiving placebo (−1.8%; p < 0.01 for both comparisons). Patients receiving either dose of MF-DPI also achieved markedly better improvements in AM and PM peak expiratory flow rates and reductions in the number of nocturnal awakenings than those observed in patients receiving placebo. Changes from baseline in overall physical function scores on the Child Health Questionnaire (CHQ-PF28) were also significantly better in patients receiving either dose of MF-DPI than in patients receiving placebo (p < 0.05 for both comparisons). MF-DPI was well tolerated, with a low incidence of treatment-related adverse events. The results from this study demonstrate that once-daily dosing with MF-DPI 100 μg or MF-DPI 200 μg in the morning is efficacious and safe for treating persistent asthma in children previously maintained on twice-daily ICS therapy.