Chronic Urticaria (CU) is a common and distressing dermatoses where release of mast cell mediators cause inflammation and accumulation and activation of other cells consisting of CD4⁺ and CD8⁺ T lymphocytes, eosinophils, basophils and neutrophils. The primary aim of treatment of CU is symptomatic relief and avoidance of triggering factors. The impact of CU on quality of life is overwhelming, including problems in home management, personal care, recreation and social interaction, mobility, emotional factors, sleep, rest and work that can lead to social isolation and altered emotional reactions.

In the search for newer modalities to supplement the pharmacotherapy for urticaria, Bepotastine, a second generation antihistamine with added effect on suppression of eosinophil migration with fewer adverse effects can be explored to reduce the burden of pills while maintaining a symptom-free interval. Furthermore, bepotastine does not interact with serotonin, muscarinic, benzodiazepine, and beta-adrenergic receptor that would otherwise result in adverse reactions such as dry mouth or sonmolence. This improved adverse effect profile can make bepotastine more tolerable to patients than the conventional antihistamines.

Thus the present study will be conducted with the objective of assessing and comparing the efficacy, safety and tolerability of Bepotastine with the standard antihistamine, Levocetrizine in chronic urticaria .

The study will be carried out in the outpatient department (OPD) of Department of Dermatology, Bankura Sammilani Medical College, Bankura, a tertiary care centre in Eastern India. Patients of either sex, aged 18 yrs to 85 years, clinically diagnosed as CU will be recruited keeping in mind the inclusion and exclusion criteria.

According to randomisation every patient will be given  either Levocetrizine 5 mg once daily or Bepotastine 10 mg twice daily at fortnightly interval for 3 months and then will be followed up for another 3 months; total study period for each patient being 6 months. Seventy eligible patients will be randomized into either group A (receiving Bepotastine) or group B (receiving Levocetrizine) with allocation ratio 1:1 as per the randomization sequence.  It is a single blind (Investigator-blind) controlled clinical trial. The dispensing and assessing physicians will be different. The assessing physician will be made un-aware (blind) of the medication dispensed. Allocation concealment will be done by sequentially numbered opaque sealed envelope (SNOSE) technique. Every patient will be followed up every two weekly for a period of 12weeks (End of treatment visit) and then monthly for 3 months with medication taken at ‘on-demand’ basis (Test of cure visit).

The number and size of wheals and degree of pruritus (grade 0, 1, 2, 3) at presentation will be recorded in a standard case record form to assess the Urticaria Severity Score (UAS) and other effectiveness parameters [Urticaria Total Severity Score (TSS), UAS7, Physicians’ and Patients’ global assessment of disease activity improvement (5 point Likert scale)]. Autologous serum skin test will be done on all patients. 0.05 ml of autologous serum will be injected immediately intra-dermally into the patients’ left flexor forearm 2 inches below the antecubital crease and 0.05 ml sterile normal saline as negative control into right forearm using 31G sterile disposable 1ml insulin syringe. The reading of the wheal will be taken after 30 minutes. This test differentiates autoreactive urticaria if positive and the response of this specific subgroup to treatment will be analysed.

There will be a provision for rescue medication throughout the study. Tablet prednisolone (0.5-1 mg/kg bd wt) may be used as rescue medication at the discretion of the treating physician. Baseline investigations will be done – Routine haemogram, random blood sugar, urea, creatinine, liver function tests (LFT) and will be repeated at 12 weeks. Spontaneously reported adverse effects and those elicited by the clinician at all follow up visits will contribute to the safety parameter.  Dermatological Life Quality Index (DLQI) will determine the quality of life in participants at baseline, 12 weeks and study end at 24 weeks.

Data will be analysed using Students’ T-test, ANOVA test for parametric data and Mann-Whitney’s test, Wilcoxon test or Friedman’s ANOVA with post hoc test for non-parametric data (as applicable). The homogeneity of the population will be tested by variance ratio test (F test) and categorical data will be analysed by using Chi-Square test and Fischer’s test as applicable. Subgroup analysis will be done for autoreactive urticaria (as per AST findings). The statistical software SPSS v 10.0 & Medcalc® v 9.6.4.0 will be used for analysis & Graph-pad Prism will be used for drawing the graphs. Modified intention to treat analysis will be done with participants reporting for at least one follow-up. Safety analysis will be done for all participants.