Journal Mobile Options
Table of Contents
Vol. 63, No. 2, 2001
Issue release date: March–April 2001

Vasomotor Rhinitis: Clinical Efficacy of Azelastine Nasal Spray in Comparison with Placebo

Gehanno P. · Deschamps E. · Garay E. · Baehre M. · Garay R.P.
To view the fulltext, log in and/or choose pay-per-view option

Individual Users: Register with Karger Login Information

Please create your User ID & Password

Contact Information

I have read the Karger Terms and Conditions and agree.

To view the fulltext, please log in

To view the pdf, please log in


The H1 antagonist azelastine is used in nasal sprays for the treatment of allergic rhinitis, but its therapeutic efficacy in vasomotor rhinitis is unknown. We performed a multicenter randomized double-blind placebo-controlled study of the efficacy and tolerance of azelastine nasal spray in 89 adult patients with vasomotor rhinitis (confirmed by negative Phadiatop). Following a washout period, patients were treated for 15 days with one puff three times daily per nostril of azelastine (n = 44) or placebo (n = 45) nasal spray. Efficacy was evaluated by the reduction in symptomatology and by rhinoscopy. Intent-to-treat analysis revealed better results in the azelastine group for all assessed symptoms; the significance level was reached for nasal obstruction on day 15 (p = 0.042). Using per protocol analysis (in 85 patients complying with the protocol), the significance level was reached for nasal obstruction on day 15 (p = 0.017) and for the percentage of success in rhinorrhea (p = 0.023). In the azelastine group, rhinoscopy examination showed a significantly higher reduction in the inflammatory level and edema of the nasal mucosa (p = 0.03 and 0.02 for VAS on day 15 respectively, per protocol analysis). General efficacy assessment by the physician and the patient was in favor of azelastine (with significance levels <0.01). No drowsiness or serious adverse event was reported, and the frequency of mouth dryness and headaches was similar in the two treatment groups. The present study demonstrates the efficacy of azelastine nasal spray in the treatment of vasomotor rhinitis. The best achieved results were a decrease in nasal obstruction and mucosal edema. Further studies are required to investigate if this therapeutic benefit results from H1 antagonism or from another, not well-characterized pharmacological action of azelastine.

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.


  1. Mikaelian AJ: Vasomotor rhinitis. Ear Nose Throat J 1989;68:207–218.

    External Resources

  2. Lund VJ and the International Rhinitis Management Working Group: International consensus report on the diagnosis and management of rhinitis. Allergy 1994;49(suppl):1–34.
  3. Weldon D: Diagnosis and management of rhinitis. Allergy Immunol 1998;25:831–848.
  4. Cervin A, Andersson M: Intranasal steroids and septum perforation – An overlooked complication? A description of the course of events and a discussion of the causes. Rhinology 1998;36:128–132.
  5. Hirschberg A, Ribari O, Kraznai M: Results obtained with Loderix tablet in chronic rhinitis patients. Ther Hung 1989;37:202–204.

    External Resources

  6. Mayeux D, Le Van D, Pitois M, Rivasseau J, Kohler C, Grilliat JP: Autonomic dysfunction in perennial vasomotor rhinitis and the effect of mequitazine. Curr Med Res Opin 1986;10:330–338.

    External Resources

  7. MacNeely W, Wiseman LR: Intranasal azelastine: A review of its efficacy in the management of allergic rhinitis. Drugs 1998;56:91–114.
  8. Fukutake T, Kusumoto T: Studies of clinical effect of E-0659 on so-called vasomotor rhinitis. Otol Fukuoka 1983;29:496–504.
  9. Wang D, Smitz J, De Waele M, Clement P: Effect of topical applications of budesonide and azelastine on nasal symptoms, eosinophil count and mediator release in atopic patients after nasal allergen challenge during pollen season. Int Arch Allergy Immunol 1997;114:185–192.

    External Resources

  10. Lung MA: The role of the autonomic nerves in the control of nasal circulation. Biol Signals 1995;4:179–185.
  11. Masini E, Rucci L, Cirri-Borghi MB, Giannella E, Mannaioni PF: Stimulation and resection of vidian nerve in patients with chronic hypertrophic non-allergic rhinitis: Effect on histamine content in nasal mucosa. Agents Actions 1986;18:251–253.

    External Resources

  12. Terrahe K: Hyperreflectoric rhinopathy. HNO 1985;33:51–57.

    External Resources

  13. Ito H, Nakamura Y, Takagi S, Sakai K: Effects of azelastine on the level of serum interleukin-4 and soluble CD23 antigen in the treatment of nasal allergy. Arzneimittelforschung 1998;48:1143–1147.
  14. Mosges R, Klimek L: Azelastine reduces mediators of inflammation in patients with nasal polyps. Allergy Asthma Proc 1998;19:379–383.
  15. Shimojo J: The effect of azelastine on bronchial mucosa in bronchial asthma – Suppression of cytokine mRNA. Arerugi 1998;47:604–613.
  16. Lieberman P: Management of allergic rhinitis with a combination antihistamine/antiinflammatory agent. J Allergy Clin Immunol 1999;103:S400–S404.

    External Resources

  17. Kuhn FA, Gonzalez S, Rodriguez M, Siller CC, Zachariou V, Goldstein BD: Capsaicin’s effect on rat nasal mucosa substance P release: Experimental basis for vasomotor rhinitis treatment. Am J Rhinol 1997;11:313–316.
  18. Stjarne P, Lundblad L, Lundberg JM, Anggaard A: Capsaicin and nicotine-sensitive afferent neurones and nasal secretion in healthy human volunteers and in patients with vasomotor rhinitis. Br J Pharmacol 1989;96:693–701.
  19. Blom HM, Godthelp T, Fokkens WJ, Klein Jan A, Mulder PG, Rijntjes E: The effect of nasal steroid aqueous spray on nasal complaint scores and cellular infiltrates in the nasal mucosa of patients with nonallergic, noninfectious perennial rhinitis. J Allergy Clin Immunol 1997;100:739–747.

    External Resources

  20. Okita W, Ichimura K: Contribution of nitric oxide and sensory transmitters to non-adrenergic, non-cholinergic innervation of nasal blood vessels. Acta Otolaryngol (Stockh) 1998;359 (suppl): 76–78.

Pay-per-View Options
Direct payment This item at the regular price: USD 38.00
Payment from account With a Karger Pay-per-View account (down payment USD 150) you profit from a special rate for this and other single items.
This item at the discounted price: USD 26.50