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.