Multicenter, Double-blind, Randomized, Placebo-controlled Study on Mometasone Furoate Nasal Spray in Japanese Pediatric Subjects with Perennial Allergic Rhinitis

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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.<br>

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