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Vol. 131, No. 2, 2003
Issue release date: June 2003
Section title: Original Paper
Int Arch Allergy Immunol 2003;131:111–118
(DOI:10.1159/000070926)

A Double-Blind Placebo-Controlled Evaluation of Sublingual Immunotherapy with a Standardized Ragweed Extract in Patients with Seasonal Rhinitis

Evidence for a Dose-Response Relationship

André C. · Perrin-Fayolle M. · Grosclaude M. · Couturier P. · Basset D. · Cornillon J. · Piperno D. · Girodet B. · Sanchez R. · Vallon C. · Bellier P. · Nasr M.
aDépartement Scientifique et Médical, Stallergènes S.A., Antony; bDépartement de Pneumologie et d’Immunologie Clinique, Centre Hospitalier Lyon Sud; cGroupement d’Allergologie et d’Immunologie, Clinique du Rhône Moyen, Lyon; dGroupe Lyonnais d’Allergologie, Lyon, and eCentre Médical PAROT, Lyon, France

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 12/5/2002
Accepted: 2/7/2003
Published online: 7/17/2009

Number of Print Pages: 8
Number of Figures: 3
Number of Tables: 5

ISSN: 1018-2438 (Print)
eISSN: 1423-0097 (Online)

For additional information: http://www.karger.com/IAA

Abstract

Background: There is a growing consensus on the benefits of sublingual-swallow immunotherapy in the treatment of allergic diseases. Methods: This randomized, double-blind placebo-controlled study was undertaken to assess the efficacy and safety of sublingual immunotherapy with standardized ragweed pollen extract tablets, in patients with an allergic rhinitis. A total of 110 outpatients were randomized (immunotherapy [I]: 55; placebo [P]: 55), of whom 99 were analyzable for efficacy (I: 48; P: 51) and 106 analyzable for safety (I: 53; P: 53). After a 28-day progression phase, the patients received a maintenance treatment during 6.5 months. Efficacy variables included a global assessment of efficacy (patient/ investigator), symptoms and medication scores as well as the frequency of asthma attacks. Results: In the active treatment group, 43 patients completed the study, versus 49 on placebo. During the whole period of pollination, the difference favoring immunotherapy was highly significant for the global assessment by the patient (p = 0.004) and by the investigator (p = 0.005). Adverse reactions were reported more often in the active treatment but mild or moderate, and they abated after dose adjustment. A subgroup analysis of those patients receiving the highest dose of immunotherapy (3 tablets 3 times a week) showed a highly significant response for rhinitis and conjunctivitis total scores by comparison to lower dosages. Conclusion: This study confirms the efficacy and safety of sublingual immunotherapy and strongly suggests a dose-response relationship.


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 12/5/2002
Accepted: 2/7/2003
Published online: 7/17/2009

Number of Print Pages: 8
Number of Figures: 3
Number of Tables: 5

ISSN: 1018-2438 (Print)
eISSN: 1423-0097 (Online)

For additional information: http://www.karger.com/IAA


Copyright / Drug Dosage

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 or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
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 goverment 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.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

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