小児通年性アレルギー性鼻炎に対するモメタゾンフランカルボン酸エステル水和物点鼻液の多施設共同，二重盲検，無作為化，プラセボ対照試験

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Background: Intranasal glucocorticoids effectively and safely alleviate the symptoms of allergic rhinitis, but treatment options from this drug class are still limited for the Japanese pediatric population. Objective: To evaluate the efficacy and tolerability of mometasone furoate nasal spray (MFNS) at a once-daily dosage compared with a placebo spray (placebo) in Japanese children with perennial allergic rhinitis (PAR). Methods: In this randomized, double-blind, multicenter study, subjects aged 5~15 years with PAR were randomly assigned to MFNS or the placebo for 2 weeks. The once-daily morning dosage of MFNS was 100 μg (50 μg per nostril) in subjects aged 5~11 years and 200 μg (100 μg per nostril) in those aged 12~15 years. The primary end point consisted of change from baseline in the total nasal symptom score (TNSS) at week 2 or discontinuation. Other efficacy end points included investigator-assessed measures of individual nasal symptoms, interference with daily activities, and global improvement. Results: Of the 333 randomized subjects, 330 completed the full 2 weeks of treatment. The between-treatment difference in TNSS at week 2 or discontinuation indicated the superiority of MFNS vs the placebo (P<0.0001). Scores for individual symptoms, interference with daily activities, and global improvement were significantly superior with MFNS vs the placebo at week 1 and week 2 or discontinuation. The overall incidence of adverse events was similar between MFNS (30.5%) and the placebo (36.3%), and all adverse events were mild to moderate. Conclusions: MFNS provided effective and rapid relief for PAR in a Japanese pediatric population while exhibiting tolerability similar to that of the placebo.
耳鼻咽喉科臨床学会の論文

小児通年性アレルギー性鼻炎に対するモメタゾンフランカルボン酸エステル水和物点鼻液の多施設共同，二重盲検，無作為化，プラセボ対照試験

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