Double-Blind Placebo-Controlled Trial of Bepotastine Salicylate in Patients With Allergic Rhinitis

Ji Hun Mo, Jin Hyeok Jeong, Tae Hoon Kim, Seon Tae Kim, Soo Whan Kim, Kun Hee Lee, Seung No Hong, Hyo Yeol Kim, Dae Woo Kim, Dong Young Kim, Chang Hoon Kim, Seok Hyun Cho, Chae Seo Rhee

Research output: Contribution to journalArticle

Abstract

Objectives/Hypothesis: To evaluate the efficacy and safety of a slow-release form of bepotastine salicylate (HL151, Belion CR) in patients with perennial allergic rhinitis (PAR). Study Design: Double-blind, placebo-controlled multicenter comparative study. Methods: Two hundred seventy-two PAR patients (aged 19–65 years) were studied to determine the efficacy and safety of HL151 (20 mg once daily administration) relative to those of a placebo in terms of improvements in total and nasal symptom scores. The subjects were randomized to the placebo (n = 138) or HL151 group (n = 134, 20 mg orally once daily for 4 weeks), and reflective and instantaneous total nasal symptom scores (TNSS) were measured daily in comparison with baseline. Among 272 subjects, 229 subjects (119 in the placebo group, 110 in the HL151 group) who completed the study were included for efficacy analysis. Results: Instantaneous and reflective TNSS and nasal symptoms such as rhinorrhea, nasal itching, and sneezing at 2 and 4 weeks showed that HL151 was superior to the placebo (all P <.05). There were no significant differences in terms of adverse events and adverse drug reactions between the two groups. Regarding serious adverse events, there was only one case of acute hepatitis B, which was reported not to be associated with HL151. Conclusions: This multicenter trial showed that once-daily use of HL151 is efficacious and safe in adult patients with PAR and could improve compliance due to its convenience. Level of Evidence: 1b Laryngoscope, 2020.

Original languageEnglish
JournalLaryngoscope
DOIs
Publication statusAccepted/In press - 2020

Keywords

  • Allergy
  • adult rhinology
  • allergic rhinitis
  • immunology
  • rhinology

ASJC Scopus subject areas

  • Otorhinolaryngology

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    Mo, J. H., Jeong, J. H., Kim, T. H., Kim, S. T., Kim, S. W., Lee, K. H., Hong, S. N., Kim, H. Y., Kim, D. W., Kim, D. Y., Kim, C. H., Cho, S. H., & Rhee, C. S. (Accepted/In press). Double-Blind Placebo-Controlled Trial of Bepotastine Salicylate in Patients With Allergic Rhinitis. Laryngoscope. https://doi.org/10.1002/lary.28906