Skin Pharmacology and Physiology
Original Research Article
Azelastine Tablets in the Treatment of Chronic Idiopathic UrticariaPhase III, Randomised, Double-Blind, Placebo and Active Controlled Multicentric Clinical Trial aHospital U. Nuestra Señora del Mar, Barcelona, bHospital General U., Valencia, cHospital U. de Puerto Real, Cádiz, dHospital U. Juan Canalejo, La Coruña, eHospital U. Doce de Octubre, Madrid, fMedical Department, ASTA Medica Spain, Madrid, Spain
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Article / Publication Details
Published online: April 13, 2001
Issue release date: March – April
Number of Print Pages: 10
Number of Figures: 5
Number of Tables: 6
ISSN: 1660-5527 (Print)
eISSN: 1660-5535 (Online)
For additional information: https://www.karger.com/SPP
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 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.
© 2001 S. Karger AG, Basel
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Article / Publication Details
Published online: April 13, 2001
Issue release date: March – April
Number of Print Pages: 10
Number of Figures: 5
Number of Tables: 6
ISSN: 1660-5527 (Print)
eISSN: 1660-5535 (Online)
For additional information: https://www.karger.com/SPP
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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