Assessment of Efficacy and Safety of Fixed-dose Combination of Ebastine and Montelukast in the Management of Allergic Rhinitis in Indian Population in Comparison to Ebastine Monotherapy: A Randomized, Multicenter Study
Srinivas CV, Chandre Gowda BV, Neeraj N Mathur, Aloke G Ghoshal, Bachi Hathiram, Rajesh A Chavan, Sunita Bage, Bimal K Mondol, Manjula S, Krishna Kumar M
Citation Information :
CV S, BV CG, Mathur NN, Ghoshal AG, Hathiram B, Chavan RA, Bage S, Mondol BK, S M, M KK. Assessment of Efficacy and Safety of Fixed-dose Combination of Ebastine and Montelukast in the Management of Allergic Rhinitis in Indian Population in Comparison to Ebastine Monotherapy: A Randomized, Multicenter Study. Int J Otorhinolaryngol Clin 2024; 16 (3):131-135.
Background and aim: There was a lack of sufficient comparative studies on ebastine, either alone or in combination with montelukast. So, this study was performed to compare the efficacy and safety of the fixed-dose combination (FDC) of ebastine 10 mg and montelukast 10 mg with ebastine 10 mg monotherapy for managing allergic rhinitis (AR) in the Indian population.
Methodology: A randomized, double-blind, multicenter, active-controlled, Phase 3 study included individuals aged 12–65 years diagnosed with mild and intermediate-severe persistent AR. The subjects were randomized into two groups: group A receiving ebastine 10 mg monotherapy and group B receiving the FDC of ebastine 10 mg and montelukast 10 mg. The efficacy of the treatment regimens was assessed through Total Symptom Scores (TSS), Investigator Symptom Scores (ISS), Visual Analog Scale (VAS) scores, and Rhinoconjunctivitis Quality of Life Survey (RQLS). Safety parameters, including biochemical assessments and adverse events, were also systematically analyzed.
Results: The results indicated a significant reduction in TSS scores in group B for nasal congestion and sneezing (ebastine 10 mg + montelukast 10 mg) compared to group A (ebastine 10 mg alone). The VAS scores demonstrated enhanced drug effectiveness in the combination group at week 2. Both groups exhibited an improved quality of life, as reflected in RQLS scores. Safety analyses confirmed the well-tolerated nature of both drug regimens, with minimal adverse events noted.
Conclusion: The FDC of ebastine 10 mg and montelukast 10 mg was more effective in reducing AR symptoms compared to ebastine 10 mg alone. The study demonstrated enhanced drug effectiveness, improved quality of life, and a well-tolerated safety profile for the combination therapy in the Indian population.
Clinical significance: The significant reduction in ISS scores for nasal congestion and sneezing in both groups highlights the positive impact of the treatments on specific symptoms associated with AR. In addition, the higher VAS score in the combination group underscores the enhanced drug effectiveness.
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