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

摘要: OBJECTIVES/HYPOTHESIS To evaluate the efficacy and safety of a slow-release form 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 (aged 19-65 years) were studied to determine HL151 (20 mg once daily administration) relative those placebo terms improvements total nasal symptom scores. The subjects randomized (n = 138) or group 134, 20 mg orally for 4 weeks), reflective instantaneous scores (TNSS) measured comparison baseline. Among 272 subjects, 229 (119 group, 110 group) who completed study included analysis. RESULTS Instantaneous TNSS symptoms such as rhinorrhea, itching, sneezing at 2 4 weeks showed that was superior (all P < .05). There no significant differences adverse events drug reactions between two groups. Regarding serious events, there only one case acute hepatitis B, which reported not be associated HL151. CONCLUSIONS This trial once-daily use is efficacious safe adult could improve compliance due its convenience. LEVEL OF EVIDENCE 1b Laryngoscope, 131:E702-E709, 2021.