Double-blind placebo-controlled study of bepotastine besilate in pediatric patients with perennial allergic rhinitis

Abstract

Background: Although second-generation antihistamines, such as bepotastine besilate, are recommended as a first-line treatment option for adult perennial allergic rhinitis (PAR), few non-sedating second-generation antihistamines are safe for children.

Objective: A double-blind, placebo-controlled, comparative study of 473 pediatric PAR patients (7 – 15 years old) to determine the superiority and safety of bepotastine besilate (10 mg twice daily) relative to placebo for improved total and individual nasal symptom scores compared with baseline.

Research design and methods: Subjects were randomized to placebo (n = 233) or bepotastine besilate (n = 240, 10 mg orally twice daily for 2 weeks). Interference of daily life by PAR was assessed by measuring change in individual nasal symptom scores from baseline.

Results: Bepotastine besilate was superior to placebo in terms of total nasal symptom scores, with improved overall nasal symptoms of PAR compared with baseline values. Subgroup analyses demonstrated bepotastine besilate was effective irrespective of age, sex or body weight. No clinically significant adverse drug reactions often observed with first-generation antihistamines were reported and no difference in adverse events between groups was observed.

Conclusions: Bepotastine besilate is effective and safe for pediatric PAR patients aged 7 – 15 years, and has a significant clinical impact on PAR. Clinical trial registration: ClinicalTrials.gov identifier: NCT01861522 (https://clinicaltrials.gov/ct2/show/NCT01861522).

Keywords:

• allergic rhinitis
• bepotastine
• children
• double-blind method
• histamine H1 antagonists

Acknowledgements

The authors thank the following clinicians for their participation: Y Kimura, M Goto, T Kokubun, T Suganuma, Hokkaido; T Takeda, K Baba, Saitama; Y Murakawa, H Tada, Y Fujimaki, K Kosaka, Chiba; S Minami, K Otsuka, C Kanazawa, K Hashiguchi, I Ogiwara, Tokyo; H Kitago, H Miho, S Sawaki, Y Hamada, T Yoshikawa, N Katsumi, K Ito, Kanagawa; A Kawai, Y Manabe, Toyama; K Yasuda, I Horikawa, Ishikawa; K Shimada, H Kikumori, A Tamaki, Osaka; T Matsuda, Y Esaki, N Soh, A Takesue, Y Satou, A Masuda, K Ishizu, Fukuoka; Y Sadanaga, Kumamoto; S Ueyama, Oita.

Declaration of interest

K Okubo acted as a consultant and medical advisor for this study and has received a consultancy fee and a scholarship from Mitsubishi Tanabe Pharma Corporation. M Ichimura, T Koyama, Y Susuta and H Izaki are employees of Mitsubishi Tanabe Pharma Corporation. This study was funded by Mitsubishi Tanabe Pharma Corporation. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance from J Ludovic Croxford and D McGowan, Edanz Group Ltd. was utilized in the production of this manuscript and funded by the Mitsubishi Tanabe Pharma Corporation.

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