ベポタスチンベシル酸塩の小児通年性アレルギー性鼻炎を対象とした長期投与試験

A long-term study of Bepotastine besilate in pediatric patients with perennial allergic rhinitis

　小児への適応拡大を目的として，７歳以上15歳以下の小児通年性アレルギー性鼻炎患者を対象に，ベポタスチンベシル酸塩20 mg/日の長期投与時の安全性及び有効性を検討した。 　目標被験者数は50名とし，多施設共同，非盲検，非対照試験で実施した。 　成人と比較して，小児での新たな副作用はなく，ベポタスチンベシル酸塩の長期投与に伴って副作用の発現頻度が増加する傾向は認められず，安全性に問題がないことが確認された。また，鼻の３主徴合計スコアをはじめとする各評価項目より有効性を検討し，治療期間を通じて，ベポタスチンベシル酸塩の持続的な鼻症状の改善効果が確認された。

　To identify additional indications for the use of bepotastine besilate in pediatric patients, we examined the safety and efficacy of long-term treatment of pediatric perennial allergic rhinitis patients, aged 7-15 years, with bepotastine besilate 20 mg/day. 　This was a multicenter, open-label, non-controlled study, and the number of subjects deemed necessary during study design was 50. 　Compared with the safety data in adults, there were no novel adverse reactions in the study subjects, and there were no differences in the proportions of adverse reactions between adult and pediatric patients. Safety risks of bepotastine besilate associated with long-term treatment of pediatric patients were within an acceptable range. Efficacy was confirmed in terms of each evaluation item, including the change from baseline in total nasal symptoms score, and bepotastine besilate showed a persistent effect on nasal symptoms throughout the treatment period. 　Trial Registration：ClinicalTrials.gov Identifier：NCT01900054