title: 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.
  
  
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01861522 ( https://clinicaltrials.gov/ct2/show/NCT01861522 ).
authors.affiliation: a 1 Nippon Medical School, Department of Otorhinolaryngology , 1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan +81 3 38 22 21 31 ; +81 3 58 14 62 07 ; ent-kimi@nms.ac.jp.
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Okubo
authors.affiliation: b 2 Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan.
authors.forename: Masahiko
authors.initials: M
authors.lastname: Ichimura
authors.affiliation: b 2 Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan.
authors.forename: Tomoya
authors.initials: T
authors.lastname: Koyama
authors.affiliation: b 2 Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan.
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Susuta
authors.affiliation: b 2 Mitsubishi Tanabe Pharma Corporation , Tokyo, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Izaki
mesh_terms: D000293:Adolescent; D002648:Child; D004311:Double-Blind Method; D006633:Histamine Antagonists / Q000627:therapeutic use*; D006801:Humans; D010880:Piperidines / Q000627:therapeutic use*; D011725:Pyridines / Q000627:therapeutic use*; D012221:Rhinitis, Allergic, Perennial / Q000188:drug therapy*
chemical_list: D006633:Histamine Antagonists; D010880:Piperidines; D011725:Pyridines; C511534:bepotastine besilate
keywords: allergic rhinitis; bepotastine; children; double-blind method; histamine H1 antagonists