PURPOSE: Current treatment guidelines recommend inhaled corticosteroids (ICS) as the cornerstone of asthma treatment in children. However, the majority of studies investigating ICS efficacy, safety, and ease-of-use have been performed in adolescent or adult populations. The safety of mometasone furoate administered via a dry powder inhaler (MF-DPI), an ICS recently approved for use in children as young as 4 years old, has been evaluated in a clinical development program of 5 randomized, double-blind, placebo-controlled clinical trials. We evaluated the safety profiles yielded by each individual trial in order to identify overall safety characteristics associated with this new addition to the pediatric asthma treatment armamentarium.
METHODS: The overall safety profile associated with MF-DPI as asthma treatment in children was investigated using pooled safety data from 5 randomized clinical trials involving asthmatic children aged 4–11 years. Doses examined were MF-DPI 110 μg QD (AM and PM), 110 μg BID, and 220 μg QD AM. The incidence of adverse events (AEs) was evaluated to determine an overall safety profile.
RESULTS: A total of 924 children taking various doses of MF-DPI were evaluated. The safety profile for MF-DPI in all 5 trials was consistent and reproducible. The AEs with the highest incidence were headache (5–21%) and upper respiratory tract infection (11–27%) (Table). No unusual AEs were observed in any of the trials, and most AEs were unrelated to treatment. Treatment-related AEs were mild and infrequent (usually 2–5%). No clinically meaningful changes were detected for vital signs, physical exams, or laboratory exams in any of the studies. AE's were mild and consistent even at twice the approved dosage, and regardless of QD AM, QD PM, or BID administration.
CONCLUSION: MF-DPI exhibited a favorable and consistent AE profile across 5 clinical trials in children 4–11 years of age with asthma.
CLINICAL IMPLICATIONS: MF-DPI has a favorable AE profile in children 4–11 years of age with asthma.
DISCLOSURE: William Berger, Grant monies (from industry related sources) Alcon, Altana, Apieron, AstraZeneca, Dey, Genentech, GlaxoSmithKline, Medpointe, Novartis, Sanofi-Aventis, Schering-Plough, Sepracor, and Teva; Consultant fee, speaker bureau, advisory committee, etc. Alcon, Altana, Apieron, AstraZeneca, Dey, Genentech, GlaxoSmithKline, Medpointe, Novartis, Sanofi-Aventis, Schering-Plough, Sepracor, and Teva; No Product/Research Disclosure Information