PURPOSE: US regulatory authorities recently approved the use of once-daily mometasone furoate administered via a dry powder inhaler (MF-DPI) for treatment of asthma in children ages 4–11 years. Using data from a pediatric clinical trial that demonstrated the efficacy of MF-DPI used once daily in the evening (QD PM), we investigated the time to onset of a significant therapeutic effect.
METHODS: Daily peak-expiratory flow (PEF) measurements were used to assess the onset of a therapeutic effect after treatment with MF-DPI in a 12-week double-blind, placebo-controlled, randomized clinical trial involving 296 asthmatic children aged 4–11 years. Children were randomized to MF-DPI 110 μg once-daily in the evening (QD PM), MF-DPI 110 μg twice-daily (BID), or placebo BID. PEF was measured in the morning and evening prior to asthma treatment and recorded in a daily diary. AM and PM PEF averages for days 1–7 and weekly averages were calculated for each treatment group. Treatment differences were evaluated by analysis of covariance. Results are presented for MF-DPI 110 μg QD PM, the approved pediatric dose. Results from the primary endpoint have been previously reported.
RESULTS: Treatment with MF-DPI 110 μg QD PM significantly improved PM PEF as early as day 1 (the first scheduled measurement; P<0.02 vs placebo), and significantly improved AM PEF beginning on day 3 (P=0.007 vs placebo). Mean improvements in PM PEF were statistically significant for 5 of the 7 days after randomization (P<0.05 vs placebo), and for each of the 12 weekly intervals throughout the treatment period (P<0.001 vs placebo). The AM PEF improvement was also sustained over 12 weeks (P≤;0.045 vs placebo).
CONCLUSION: Treatment of asthmatic children ages 4–11 years with MF-DPI was associated with rapid and sustained improvement in PEF.
CLINICAL IMPLICATIONS: The therapeutic effect of once-daily pediatric MF-DPI treatment is rapid and sustained.
DISCLOSURE: Henry Milgrom, Grant monies (from industry related sources) Dr. Milgrom has received study support from Schering-Plough, Genentech, Novartis, GlaxoSmithKline, Sepracor, AstraZeneca, and Sanofi-Aventis.; Consultant fee, speaker bureau, advisory committee, etc. Dr. Milgrom has served on speaker's bureaus and advisory boards for Schering-Plough, Novartis, and Genentech.; No Product/Research Disclosure Information