Volume 5 Supplement 4

Abstracts from the 10th Symposium of Experimental Rhinology and Immunology of the Nose (SERIN 2015)

Open Access

MP29-02*’s advanced delivery system contributes to its efficacy in patients with moderate/severe seasonal allergic rhinitis

  • Glenis Scadding1,
  • Claus Bachert2,
  • Peter Hellings3,
  • Wytske Fokkens4,
  • Ullrich Munzel5 and
  • Ralph Mösges6
Clinical and Translational Allergy20155(Suppl 4):P36

https://doi.org/10.1186/2045-7022-5-S4-P36

Published: 26 June 2015

Background

Four previously published trials assessed the efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in an advanced delivery system) in seasonal allergic rhinitis (SAR) [1, 2]. The first study compared MP29-02* to marketed AZE and FP [2]. The others compared MP29-02* to AZE and FP in the MP29-02* vehicle and delivery device (i.e. re-formulated comparators) [1]. FP contained within MP29-02* has a unique PK fingerprint [3]. The aim of this analysis was to demonstrate that formulation/device contribute to MP29-02*’s clinical efficacy.

Methods

Four thousand and five moderate/severe SAR patients (≥12 yrs old) were randomized into 4 double-blind, placebo (PLA)-controlled trials. Each trial comprised 4 groups: MP29-02*, AZE, FP and PLA nasal sprays, and was conducted for 14 days. Total daily dose of AZE and FP were 548 µg and 200 µg, respectively. Change from baseline (CFB) in reflective total nasal symptom score (rTNSS) over 14-days was the primary outcome. CFB in reflective total ocular symptom score (rTOSS) and individual nasal and ocular symptoms was assessed secondarily. Time to achieve at least a 50% rTNSS reduction from baseline was assessed post-hoc by Kaplan Meier estimates and log rank tests. The formulation/device effect of MP29-02* was quantified by comparing treatment differences obtained with MP29-02* vs marketed FP and MP29-02* vs re-formulated FP for these endpoints.

Results

For all efficacy variables assessed, the treatment difference was greater for MP29-02* vs marketed-FP than for MP29-02* vs re-formulated-FP. For rTNSS, the difference between MP29-02* and marketed-FP was -1.47, compared to -0.76 vs reformulated-FP; a formulation/device effect of 0.71. Similarly for rTOSS a formulation/device effect of 0.70 was observed. A formulation/device effect was observed for relief of all individual nasal and ocular symptoms (e.g. 0.23 effect for congestion; 0.34 effect for ocular itching). Finally, MP29-02*-patients achieved a ≥50% rTNSS reduction ≤6 days faster than marketed-FP and ≤3 days faster than reformulated-FP, a formulation/device effect of ≤3 days.

Conclusion

Formulation and device contribute to MP29-02*’s superior efficacy over currently considered firstline therapy, making MP29-02* a new class of treatment for AR.

*Dymista

Authors’ Affiliations

(1)
The Royal National Throat Nose and Ear Hospital
(2)
Department of Oto-Rhinolaryngology, Ghent University Hospital
(3)
Dept of Otorhinolaryngology, Head & Neck Surgery, University Hospitals Leuven
(4)
Department of Otorhinolaryngology, Academic Medical Center
(5)
Meda, Corporate Clinical Affairs
(6)
University of Cologne, IMSIE

References

  1. Carr W, Bernstein P, Lieberman , Meltzer E, Bachert C, Price D, et al: JACI. 2012, 129 (5): 1282-1289.Google Scholar
  2. Meltzer E, Ratner P, Bachert C, Carr W, Berger W, Canonica GW, et al: Int Arch Allergy Immunol. 2013, 161 (4): 369-377. 10.1159/000351404.View ArticlePubMedGoogle Scholar
  3. Derendorf H, Munzel U, Petzold U, Maus J, Mascher H, Hermann R, et al: Int Arch Allergy Immunol. 2013, 74 (1): 125-133.Google Scholar

Copyright

© Scadding et al. 2015

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/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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