Long-term safety of mometasone furoate administered via a dry powder inhaler in children: Results of an open-label study comparing mometasone furoate with beclomethasone dipropionate in children with persistent asthma.

BACKGROUND: To assess the long-term pediatric safety of 2 doses of mometasone furoate administered via a dry powder inhaler (MF-DPI) for mild-to-moderate persistent asthma and compare them with that of beclomethasone dipropionate administered via a metered dose inhaler (BDP-MDI) in the treatment of persistent asthma. Both MF-DPI doses tested are twice the approved pediatric dosage of 100 microg once-daily (QD) for children aged 4-11 years.

METHODS: Children (N = 233) aged 4-11 years were randomized to 52 weeks of treatment with MF-DPI 200 microg QD AM, MF-DPI 100 microg twice daily (BID), or BDP-MDI 168 microg BID. Patients had used inhaled corticosteroids (ICSs) daily for > or = 30 days before the screening visit and were on stable ICS doses for > or = 2 weeks before screening. The primary safety variable was the incidence of adverse events. Secondary safety variables were laboratory tests (including cortisol concentrations), vital signs, and physical examination.

RESULTS: The incidence of adverse events was similar in all 3 treatment groups. The most frequently reported adverse event was upper respiratory tract infection, reported by 47%-49% of the MF-DPI-treated patients and 51% of the BPD-treated patients. Most adverse events were considered unrelated to study drug. The most frequently reported related adverse events were headache (MF-DPI 200 microg QD AM, 8%; MF-DPI 100 microg BID, 4%; BDP-MDI 168 microg BID, 2%) and oral candidiasis (4% in each treatment group). No clinically relevant changes in laboratory values, including plasma cortisol, vital signs, or physical examinations were noted in any treatment group.

CONCLUSION: 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 microg BID.