Table of Contents
Journal of Allergy
Volume 2014, Article ID 297203, 12 pages
http://dx.doi.org/10.1155/2014/297203
Clinical Study

Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

1Private Health Centre, Institute for ENT Elmshorn, Hermann-Ehlers-Weg 4, 25337 Elmshorn, Germany
2Joint Practice for ENT, Willy-Brandt Straße 2, 21335 Lüneburg, Germany
3Bitop AG, Stockumer Straße 28, 58453 Witten, Germany

Received 28 February 2014; Revised 5 May 2014; Accepted 6 May 2014; Published 28 May 2014

Academic Editor: Ralph Mösges

Copyright © 2014 Uwe Sonnemann et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.