Efficacy and tolerability comparison of ebastine 10 and 20mg with loratadine 10mg - A double-blind, randomised study in patients with perennial allergic rhinitis

Objective: To compare the dose-related efficacy and tolerability of the oral H-1 antihistamine ebastine (10 or 20mg) with a reference drug, loratadine(10mg), in the once-daily treatment of perennial allergic rhinitis (PAR). Patients and Methods: The trial was conducted in 317 patients (aged 12 to 68 years) with ongoing symptoms of PAR. Mean 24-hour diary card symptom severity scores (0-3) were compared as changes from baseline between the randomised, double-blind treatment groups over a it-week period. Results: Symptom scores, including both 'perennial index' (PIN = sneezing + nasal itching + discharge) and total 'nasal index' (TNI = PIN + nasal stuffiness) showed statistically significantly greater improvements with ebastine 10 or 20mg than with loratadine 10mg for all parameters except sneezing, itching and ocular symptoms. The mean TNI scores were reduced by 44, 47 and 32%, respectively, over 4 weeks, and treatment differences were apparent from week 1 onwards. Patient and physician final opinions (percentage of patients improved) were also significantly in favour of ebastine (79 to 85%) vs loratadine (65 to 66%). The treatments were equally well tolerated and no serious adverse events occurred. Conclusion: This study found ebastine 10 or 20mg to be more effective than loratadine 10mg for the treatment of PAR.