Volume 3 Supplement 2

9th Symposium of Experimental Rhinology and Immunology of the Nose (SERIN 2013): Abstracts

Open Access

A new efficacy parameter (complete/near complete symptom relief) in allergic rhinitis management: results with a new therapy MP29-02*

  • Jean Bousquet1,
  • Glenis Scadding2,
  • David Price3,
  • Peter Hellings4,
  • Wytske Fokkens5,
  • Ullrich Munzel6 and
  • Claus Bachert7
Clinical and Translational Allergy20133(Suppl 2):P42

DOI: 10.1186/2045-7022-3-S2-P42

Published: 16 July 2013

Background

It is unclear what constitutes a clinically-meaningful response for allergic rhinitis (AR) outcomes. In a recent survey [1] most experts defined control as being "hardly troubled at all" by each symptom. We propose a new criterion of ≤1 point remaining in each nasal symptom score (Max AM+PM score for each symptom=6) of the reflective total nasal symptom score (rTNSS) to stringently test efficacy and provide an endpoint meaningful to physicians and patients. This criterion has been termed complete/near-to-complete symptom control. Any treatment providing this level of control (patients will feel "cured") should have considerable socioeconomic impact.

Objective

To compare the proportion of patients achieving ≤1 point remaining in each of the 4 symptoms of the rTNSS (congestion, itching, rhinorrhoea & sneezing) and the time taken to achieve this response in patients treated with MP29-02* (a novel intranasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP]), FP, AZE or placebo (PLA) nasal sprays.

Methods

610 patients (≥12 years old) with moderate-to-severe seasonal AR were randomized into a double-blind, placebo-controlled, 14 day parallel-group trial to receive MP29-02*, commercially-available AZE or FP nasal sprays or PLA nasal spray (all 1 spray/nostril bid; total daily dose [AZE: 548µg, FP: 200µg]). The primary outcome was change from baseline in rTNSS over 14-days. Time to achieve ≤1 point remaining in each nasal symptom (AM + PM) of the rTNSS was assessed post-hoc by Kaplan-Meier estimates and log rank tests.

Results

17.8% of MP29-02* patients (1 out of 6) achieved this response versus 8.3%, 9.2% and 7.8% of those treated with AZE, FP and PLA, respectively. MP29-02* patients achieved this response up to 7 days faster than AZE (p=0.0152) and up to 8 days faster than either FP (p=0.0262) or PLA (p=0.0094). Neither AZE nor FP differed from PLA for this parameter.

Conclusion

MP29-02* provides faster and more complete symptom control than first-line therapies for AR. One out of 6 moderate to severe AR patients achieved complete/near-to-complete and uniform symptom relief days faster than either FP or AZE. MP29-02* is the drug of choice for AR treatment since it was the only therapy to rapidly provide such a level of symptom control. This endpoint should become a new standard in assessing the efficacy of current and novel AR therapy.

*Dymista

Authors’ Affiliations

(1)
Hopital Arnaud de Villeneuve University Hospital
(2)
The Royal National Throat, Nose and Ear Hospital
(3)
Dept of General Practice & Primary Care, University of Abderdeen
(4)
Dept of Otorhinolaryngology, Head and Neck Surgery, University Hospitals Leuven
(5)
Dept of Otorhinolaryngology, Academic Medical Center
(6)
Meda Pharma, Biostatistics & Market Access
(7)
Ghent University Hospital, Dept of Oto-rhinolaryngology

References

  1. Scadding G: Poster. BSACI. 201-Google Scholar

Copyright

© Bousquet et al; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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