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

Background: The efficacy and safety of mometasone furoate aqueous nasal spr ay (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 pediatri c patients has not yet been characterized. Objective: This study was conduc ted to determine the dose-response relationship of 3 different doses of MFN S in a pediatric population. Methods: This was a multicenter, double-blind, active- and placebo-controll ed study of 679 children 6 to 11 years of age with histories of SAR and doc umented positive skin test responses. Patients were randomized to one of th e 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 per formed 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 nasa l symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the pla cebo group (P less than or equal to.02). No significant differences were ob served among the 3 MFNS groups. However, as treatment continued, symptoms i n patients treated with MFNS 100 or 200 mu g once daily continued to improv e, whereas those treated with MFNS 25 mu g once daily demonstrated little f urther improvement. By day 29, MFNS 100 and 200 mu g once daily both were s ignificantly more effective than MFNS 25 mu g once daily in relieving sympt oms 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 te sts performed before and after treatment found no evidence of hypothalamic- pituitary-adrenal axis suppression. Conclusion: These results indicate that the most appropriate therapeutic do sage of MFNS in the treatment of SAR in children 6 to 11 years of age is 10 0 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-p ituitary-adrenal axis function.