A Randomized, Open Label, Prospective, Comparative, Multicentric Study to Evaluate the Efficacy and Safety of Montelukast and Fexofenadine Fixed-dose Combination vs Montelukast and Levocetirizine Fixed-dose Combination in Allergic Rhinitis.

ABSTRACT

Background: Allergic rhinitis (AR) has impact on the physical, psychological and social aspects of the patients’ life and work. Therefore, it is imperative to identify the treatment options for AR. Objective: This randomized, open label, prospective, two arm, comparative, multicentric study evaluated the efficacy and safety of montelukast 10 mg + fexofenadine 120 mg (MF) fixed dose combination (FDC) versus montelukast 10 mg + levocetirizine 5 mg (ML) FDC in subjects with AR. Materials and methods: The adult subjects were randomized to either treatment ML (n = 62), MF (n = 56), administered once-daily for 14 days. The primary endpoint was the change in total symptom score (TSS) (the sum of total nasal symptom score [TNSS]) and total ocular symptom score (TOSS]) at the end of study as compared to baseline. The secondary endpoints were TNSS and TOSS At the end of study as compared to baseline, physician’s and patient’s global assessment for efficacy and tolerability and adverse events. Results: Both groups were comparable with respect to demographic characters and vital parameters. In MF group, the reduction in TSS at the end of study was 93.86% as compared to 87.71% in ML. The changes in TNSS and TOSS at the end of study were 92.52% and 95.34% in MF group as compared to 85.58% and 92.23% in ML group. Global impression by investigator showed 53.23% subjects rated excellent to very good with MF as compared to 36.36% subjects with ML. Global impression by subjects showed excellent to very good rating for 50% subjects with MF and for 34.54% subjects with ML. Conclusions: Montelukast + fexofenadine showed better improvement in symptoms of AR and a better global impression by both investigators and subjects compared to montelukast + levocetirizine.