Effects of bepotastine, a nonsedating H1-antihistamine, for the treatment of persistent cough and allergic rhinitis: a randomised, double-blind, placebo-controlled trial

Abstract

Background: Empirical therapy with oral histamine-1 receptor antagonists (H1RAs) is often used for patients with suspected upper airway cough syndrome. No placebo-controlled trials with nonsedating H1RAs (nsH1RAs) have evaluated validated cough outcomes. The objective of the present study was to assess the effect of an nsH1RA, bepotastine, on cough outcomes in patients with allergic rhinitis and persistent cough.

Methods: A randomised, double-blind, placebo-controlled trial was conducted. Adult patients with persistent cough (>3 weeks in duration) and symptomatic allergic rhinitis were recruited and randomly assigned to receive either bepotastine or placebo at a 1:1 ratio. The primary outcome was cough-specific quality of life assessed using the Leicester Cough Questionnaire (LCQ). Secondary outcomes included cough severity visual analogue scale (VAS), throat VAS, Cough Hypersensitivity Questionnaire, Sinonasal Outcome Test-22 score and drug adverse events.

Results: Between October 2021 and September 2022, 50 participants (43 females; mean age 46.28 years; median cough duration 3 months) were assigned to either the bepotastine 10 mg twice daily or placebo group in a 1:1 ratio. After 2 weeks of treatment, both bepotastine and placebo groups showed significant improvements in the LCQ scores, but there was no significant difference in the magnitude of change between the groups (3.45±2.10 versus 3.04±2.94, p=0.576). Secondary outcomes were also comparable.

Conclusions: Despite the relatively small sample size, our study clearly demonstrated that a 2-week treatment with bepotastine did not provide therapeutic benefits for cough outcomes. These findings suggest against the use of nsH1RAs with the intention of improving cough outcomes, even in patients with persistent cough and allergic rhinitis.

FIGURE 1

Overview of study design. After screening and baseline assessment, 50 participants were randomised to a 2-week treatment with either bepotastine (10 mg twice daily) or placebo. One subject in the placebo group was lost to follow-up, and 49 subjects completed the study.

FIGURE 2

Comparison of clinical outcomes after the 2-week intervention in the bepotastine group and the placebo group. Data are presented as mean±sd. LCQ: Leicester Cough Questionnaire; CHQ: Cough Hypersensitivity Questionnaire; VAS: visual analogue scale; SNOT-22: Sinonasal Outcome Test-22.

FIGURE 3

Changes in clinical outcomes before and after the intervention in the bepotastine group and the placebo group. Data are presented as mean±sd. a) Leicester Cough Questionnaire (LCQ) score, b) Cough Hypersensitivity Questionnaire (CHQ) score, c) cough severity visual analogue scale (VAS), d) throat VAS and e) Sinonasal Outcome Test (SNOT)-22 score.