Efficacy and safety of ebastine 10 mg and phenylephrine 10 mg fixed-dose combination in Indian patients with allergic rhinitis: A phase 4 multicentre study

Abstract

There is a lack of comprehensive studies examining the efficacy and safety of the fixed-dose combination (FDC) of ebastine 10 mg and phenylephrine 10 mg in allergic rhinitis (AR), especially in Indian settings. So, this study aimed to fill the existing research gap by evaluating the efficacy and safety of the FDC ebastine 10 mg and phenylephrine 10 mg in Indian patients with moderate/severe persistent AR.An open-label, non-randomized, single-group, multicentric, phase 4 clinical study included adult patients visiting the outpatient departments of 4 sites across India. All the selected subjects received the FDC once daily in the evening for 5 days. Safety and efficacy of the FDC were evaluated by comparing the Individual Symptoms Score (ISS), Total symptom Score (TSS), and analysing adverse event profiles reported by patients, assessed by the investigator, from baseline to 6 days. The study also assessed the impact of this condition on patients' quality of life using the rhino-conjunctivitis quality of life scale (RQLS). The study included 145 participants with a mean age of 37.17 ± 12.65 years and male-to-female ratio of 1:1.26. Comparison of baseline symptoms with day 6 revealed statistically significant and clinically meaningful improvements in Individual Symptoms Score (ISS). The mean difference in Total Symptom Score (TSS) from baseline to day 6 also showed a substantial improvement of 3.52 ± 1.54 (95% CI: 3.27-3.78; P <0.001). Rhino-conjunctivitis quality of life scale (RQLS) also demonstrated statistically significant improvement from day 1 to day 6 (t = 24.44, P <0.001). Adverse events were effectively managed with the use of readily available over-the-counter medications like antipyretics, analgesics, and/or antacid.The study validated the efficacy and safety of the FDC ebastine 10 mg and phenylephrine 10 mg, in managing AR with good safety profile. The findings underscore the importance of this combination as a viable therapeutic option, with significant improvements in symptom scores and quality of life observed within a short duration.