A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis

Background: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 mu g once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized. Objective: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population. Methods: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 mu g once daily, MFNS 100 mu g once daily, MFNS 200 mu g once daily, beclomethasone dipropionate 84 mu g twice daily (168 mu g/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29. Results: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (P less than or equal to.02). No significant differences were observed among the 3 MFNS groups. However, as treatment continued, symptoms in patients treated with MFNS 100 or 200 mu g once daily continued to improve, whereas those treated with MFNS 25 mu g once daily demonstrated little further improvement. By day 29, MFNS 100 and 200 mu g once daily both were significantly more effective than MFNS 25 mu g once daily in relieving symptoms of SAR, but MFNS 200 mu g provided no additional benefit over MFNS 100 mu g. All doses of MFNS were well tolerated, and cosyntropin stimulation tests performed before and after treatment found no evidence of hypothalamic-pituitary-adrenal axis suppression. Conclusion: These results indicate that the most appropriate therapeutic dosage of MFNS in the treatment of SAR in children 6 to 11 years of age is 100 mu g once daily. In addition, MFNS at doses up to 200 mu g once daily for 4 weeks was well tolerated and had no detectable effects on hypothalamic-pituitary-adrenal axis function.