To assess the long-term pediatric safety of mometasone furoate dry powder inhaler (MF-DPI) and compare it with that of beclomethasone dipropionate metered dose inhaler (BDP-MDI).
Children (N = 233) aged 4 –11 years were randomized to 52 weeks of treatment with MF-DPI 200 mcg qd AM, MF-DPI 100 mcg bid, or BDP-MDI 168 mcg bid. Subjects had used ICS daily for ≥ 30 days before the screening visit, and were on stable ICS doses for ≥ 2 weeks before screening. The primary safety variables were adverse events. Secondary safety variables included vital signs and physical examination.
The incidences of treatment-emergent adverse events were similar in all three treatment groups. The most frequently reported adverse event was upper respiratory tract infection, reported by 47% to 51% of subjects. Most adverse events were considered unrelated to study drug, and those considered related to treatment were consistent with all treatment-emergent adverse events. The most frequently reported related adverse events were headache (MF-DPI 200 mcg qd AM, 8%; MF-DPI 100 mcg bid, 4%; BDP-MDI 168 mcg bid, 2%) and oral candidiasis (4% in each treatment group). No clinically relevant changes in laboratory values, vital signs, or physical examinations were noted in any treatment group.
Both MF-DPI doses were well tolerated, with no unusual or unexpected adverse events or safety concerns, and had a similar adverse event profile to that of BDP-MDI 168 mcg bid.
MF-DPI is a well-toleratd ICS for the treatment of pediatric asthma.
M. Noonan, Schering-Plough Research Institute