Randomized prospective double-blind comparative clinical study of ebastine and its combined preparation of montelukast in persistent allergic rhinitis

Abstract

Background: Antiallergic drugs are widely prescribed in allergic rhinitis (AR). Antihistamines and antileukotrienes are effective only in providing symptomatic relief of allergic symptoms, often used as fixed dose combinations (FDC) of both. Controversial reports regarding their efficacy in AR, when used alone or in their combined preparations, prompted the present study. Aims and Objectives: The aim of this study was to compare the anti-allergic effect of ebastine, montelukast, and their FDC on the subjective nasal and extranasal symptoms in mild-to-moderate persistent AR (PAR) patients. Materials and Methods: Mild-to-moderate PAR patients divided into three groups to receive drugs ebastine, montelukast, and their combined preparation for 3 weeks. Their efficacy was measured by total five nasal symptoms scoring system, AM, and PM symptom scores. The treatment was withdrawn in the last week, to assess the persisting anti-allergic action of treatment drugs. Results: When compared to baseline values, all the treatment groups showed a significant decrease in the total mean score of allergic symptoms. Ebastine and its combination with montelukast significantly decreased both AM and PM mean scores, but montelukast did only for PM mean score. Among three compared groups, ebastine and its combined preparation with montelukast were found significant in reducing total and AM symptoms. Conclusion: All 3 groups showed anti-allergic effects in a variable manner. Montelukast controlled daytime symptoms better. Ebastine and its combination with montelukast controlled allergic symptoms to a similar extent.