title: Efficacy and safety of bilastine in Japanese patients with perennial allergic rhinitis: A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase III study.
abstract: BACKGROUND
  Bilastine, a novel non-sedating second-generation H1antihistamine, has been approved in most European countries since 2010. This study aimed to evaluate the superiority of bilastine over placebo in Japanese patients with perennial allergic rhinitis (PAR).
  
  
  METHODS
  This randomized, double-blind, placebo-controlled, parallel-group, phase III study (trial registration number JapicCTI-142600) evaluated the effect of a 2-week treatment period with bilastine (20 mg once daily), fexofenadine (60 mg twice daily), or a matched placebo (double dummy) in patients with PAR. All patients were instructed to record individual nasal and ocular symptoms in diaries daily. The primary endpoint was the mean change in total nasal symptom scores (TNSS) from baseline to Week 2 (Days 10-13).
  
  
  RESULTS
  A total of 765 patients were randomly allocated to receive bilastine, fexofenadine, or placebo (256, 254, and 255 patients, respectively). The mean change in TNSS from baseline at Week 2 was significantly decreased by bilastine (-0.98) compared to placebo (-0.63, P = 0.023). Bilastine and fexofenadine showed no significant difference in the primary endpoint. However, the mean change in TNSS from baseline on Day 1 was more significantly decreased by bilastine (-0.99) than by placebo (-0.28, P < 0.001) or fexofenadine (-0.62, P = 0.032). The active drugs also improved instantaneous TNSS 1 h after the first and before the second drug administration on Day 1 (P < 0.05). The study drugs were well tolerated.
  
  
  CONCLUSIONS
  After 2-week treatment period, bilastine 20 mg once daily was effective and tolerable in Japanese patients with PAR, and exhibited a rapid onset of action.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Nippon Medical School, Tokyo, Japan. Electronic address: ent-kimi@nms.ac.jp.
authors.forename: Kimihiro
authors.initials: K
authors.lastname: Okubo
authors.affiliation: Department of Otolaryngology, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.
authors.forename: Minoru
authors.initials: M
authors.lastname: Gotoh
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Kansai Medical University, Osaka, Japan.
authors.forename: Mikiya
authors.initials: M
authors.lastname: Asako
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, Nihon University, Tokyo, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Nomura
authors.affiliation: Clinical Development Division, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Michinori
authors.initials: M
authors.lastname: Togawa
authors.affiliation: Clinical Development Division, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Saito
authors.affiliation: Clinical Development Division, Taiho Pharmaceutical Co., Ltd., Tokyo, Japan.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Honda
authors.affiliation: Ohashi ENT & Allergic Clinic, Osaka, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000328:Adult; D044466:Asian People; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000008:administration & dosage* / Q000009:adverse effects; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016593:Terfenadine / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D001562:Benzimidazoles; D010880:Piperidines; D016593:Terfenadine; C093230:fexofenadine; C445659:bilastine
keywords: Bilastine; Fexofenadine; H(1)-antihistamine; Perennial allergic rhinitis; Total nasal symptom score