A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis. |
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| Authors: | E O Meltzer W E Berger R B Berkowitz E A Bronsky D J Dvorin A F Finn S P Galant J Grossman F C Hampel P H Ratner M E Ruff E J Schenkel A T Segal N Segall G E Stewart I Tripathy D P Skoner R Anolik R J Dockhorn J van Bavel B Mesarina-Wicki K Nolop |
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| Affiliation: | Allergy and Asthma Medical Group and Research Center, San Diego, CA, USA. |
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| Abstract: | BACKGROUND: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 microg 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 microgram once daily, MFNS 100 microgram once daily, MFNS 200 microgram once daily, beclomethasone dipropionate 84 microgram twice daily (168 microgram/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
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