Azelastine tablets in the treatment of chronic idiopathic urticaria -: Phase III, randomised, double-blind, placebo and active controlled multicentric clinical trial

This trial was designed to study the efficacy and tolerability of azelastine in controlling symptoms of chronic idiopathic urticaria, using ebastine as validation group. Fifty-two adult patients were randomised to receive azelastine (4 mg), ebastine (10 mg) or 18 placebo for 21 days. Patients were required to visit the investigating physicians on three different occasions (days 0, 7 and 21). On each of these three study days, investigators assessed itching, wheals and erythema, based on a 4-point scale, and quality of life using a visual-analogue scale and subscale 9 of the Short Form 36 (SF-36) Health Survey. Patients entered daily assessments of itching on diary cards also using a 4-point scale. Furthermore, investigators assessed global efficacy and tolerability of the study medication on day 21 or upon premature discontinuation of the trial. Side effects and compliance were evaluated on each visit. A statistically significant reduction in itching was found for both active treatments compared with placebo. These improvements, which were statistically significant already after 1 day of treatment, continued over the course of 3 weeks. Additionally, both azelastine and ebastine were effective in improving symptoms such as wheals and erythema when compared to placebo. The quality-of-life parameters were unaffected by either treatment. Taste perversion (2 cases) and somnolence (1 case) were the only adverse drug reactions of azelastine. Ebastine, however, seemed to cause more often and more severe symptoms such as fatigue, sleepiness and asthenia. Global assessments of efficacy and tolerability performed by the investigators, also favoured azelastine. In conclusion, both azelastine and ebastine are effective and safe drugs, able to control symptoms of chronic idiopathic urticaria since the first day of treatment, and along a period of 3 weeks. Copyright (C) 2001 S. Karger AG, Basel.