An Open Label Randomized Comparative Clinical Trial on Efficacy and Safety of Bilastine Tablet, Fluticasoneand Mometasone Nasal Spray in Allergic Rhinitis; A Tertiary Care Hospital Based Prospective Interventional Study

Background: Corticosteriods nasal sprays are the mainstay of treatment for allergic rhinitis. Most common reasons for patients to be dissatisfied with treatment for allergic rhinitis are inadequate symptom relief and bothersome side effects with intranasal corticosteroids. Bilastine tablet has high specificity and prolong duration of binding to H1 receptor and hence demonstrates antihistamine and antiallergic properties and hence the present study is to compare the efficacy, safety and compliance of bilastine tablet, fluticasone and mometasone nasal spray in allergic rhinitis. Objective : To determine the efficacy, safety and clinical outcome of bilastine tablet, fluticasone and mometasone nasal spray in allergic rhinitis. Material and Methods: This single-center, open label randomized interventional clinical trial was conducted in the department ofOtorhinolaryngology (ENT) and department of Pharmacology, Indira Gandhi Medical College and Hospital, Shimla. For this study 240 allergic rhinitis patients aged 18-50 years, satisfying the eligibility criteria were randomized into 3 groups in a 1:1:1 ratio to receive either the bilastine tablet 20mg or fluticasone furoate 50mcg or mometasone furoate 50mcg nasal spray. Baseline lab investigations of absolute eosinophill count, hemoglobin, random blood sugar, renal function test, liver function test, nasal endoscopy and SNOT-22 score were documented. After 6 weeks of active treatment, the study drugs were withdrawn, lab investigations of hemoglobin, renal function test, liver function test were done and documented. SNOT-22 and Medication Adherence Rating Scale (MARS) questionnaire were completed.Results: In bilastine group the mean baseline SNOT-22 score was 37.85+ 15.818 which decreased to 3.35 + 7.388 after 6 weeks. (P value 0.001). In mometasone nasal spray group the mean baseline SNOT-22 score was 37.79 + 11.829 which decreased to 2.8 + 4.772 after 6 weeks. (P value 0.001). In fluticasone nasal spray group the mean baseline SNOT-22 score was 37.68 + 15.475 which decreased to 2.34 + 5.116 after 6 weeks. (P value 0.001). Mean of baseline and post intervention vitals and laboratory parameters in bilastine, mometasone and fluticasone groups was statistically non significant. (P value > 0.05). No ADR/AE reported in any group. Only 1 patient in bilastine and 4 in mometasone and fluticasone group were non-compliant. Hence, 6 weeks of therapy with these three medications, were 100% efficacious and safe. Conclusion: Bilastine tablet once daily is equally efficacious and safe to use as compared to twice daily regime of fluticasone and mometasone nasal spray. Compliance to intranasal corticosteroids, mometasone and fluticasone nasal spray is compromised as compared to oral anti histaminic tablet bilastine in allergic rhinitis. Hence therapy may be based on patient preference, convenience and cost.

TrialRegistration : The clinicalTrials.gov Identifier is CTRI/2023/10/058841.