フランカルボン酸モメタゾン点鼻液の通年性アレルギー性鼻炎における用法用量検討試験

概要

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A randomized, double-blind placebo-controlled, parallel-group, comparative study was conducted in 455 patients with perennial allergic rhinitis in order to examine the recommended dosage and administration of mometasone fuorate (MF) nasal spray for the treatment of allergic rhinitis in Japanese subjects over 2 weeks. Subjects were randomized to 6 treatment groups: (placebo: 77; 100 μg/day QD: 75; 200 μg/day QD: 74; 400 μg/day QD: 79; 200 μg/day BID: 75; and 400 μg/day BID: 75). All subjects were evaluated for safety and efficacy. The primary efficacy endpoint, decrease in individual nasal symptoms and overall improvement at week one and at the end of treatment for subjects treated with MF 200 μg/day or higher were significantly better than those of the placebo group (p<0.05). The incidence of adverse events was comparable among treatment groups. Based on the findings of safety and efficacy,200 μg/day QD was considered the most appropriate MF dose for treatment of patients with allergic rhinitis.
耳鼻咽喉科臨床学会の論文