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

Skin Pharmacology and Applied Skin Physiology
J M CamarasaI Tagarro

Abstract

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 wheal...Continue Reading

Citations

Jan 27, 2006·Allergy·T ZuberbierB Wedi
Nov 23, 2007·Dermatology : International Journal for Clinical and Investigative Dermatology·Laurence Le CleachOlivier Chosidow
Sep 1, 2005·Expert Review of Clinical Immunology·Bettina Wedi, Alexander Kapp
Sep 24, 2009·Allergy·T ZuberbierUNKNOWN World Allergy Organization
Nov 15, 2014·The Cochrane Database of Systematic Reviews·Maulina SharmaBen Carter
Nov 8, 2013·Expert Opinion on Pharmacotherapy·Michael MakrisTorsten Zuberbier
Jan 4, 2013·The World Allergy Organization Journal·Mario Sánchez-BorgesUNKNOWN WAO Scientific and Clinical Issues Council

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