Safety and efficacy of mometasone furoate aqueous nasal spray in children with allergic rhinitis: Results of recent clinical trials

Abstract

Intranasal mometasone furoate (MF) has been extensively studied in adults and has been found to be safe and effective therapy for the treatment of allergic rhinitis. Several studies have now been conducted on pediatric patients. In all, 990 pediatric patients given mometasone furoate nasal spray (MFNS) have been studied in phase I, II, and III clinical trials. In a dose-ranging study, 5 doses of nasal spray (25, 100, and 200 μg MFNS daily and 168 μg beclomethasone dipropionate daily) were compared with placebo. The 100- and 200-μg daily doses of MFNS were found to be more effective than 168 μg beclomethasone dipropionate or 25 μg MFNS given daily. MFNS (100 μg once daily) was chosen as the appropriate dose. In clinical efficacy and safety trials, MFNS was given to 381 patients 3 to 11 years of age for 4 weeks (357 patients received 100 μg MFNS daily for 6 months) and was found to decrease symptom scores from baseline significantly better than placebo. The long-term safety of MFNS was also studied in 166 patients treated for one year; no significant changes in intraocular pressure were detected. Cosyntropin stimulation showed no decreases in cortisol. In adults, nasal mucosa showed improvement in appearance of epithelium and reduction of inflammatory infiltrates, and there were no signs of nasal atrophy. © 2001 Mosby, Inc.