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PD15 - MP29-02 effectively relieves both nasal and ocular symptoms in adolescents aged 12-17 years: results from a meta-analysis of 4 randomised controlled Seasonal Allergic Rhinitis (SAR) trials

  • Erkka Valovirta1,
  • Ruth Murray2,
  • Ullrich Munzel3 and
  • Nikos Papadopoulos4
Clinical and Translational Allergy20144(Suppl 1):P15

https://doi.org/10.1186/2045-7022-4-S1-P15

Published: 28 February 2014

Keywords

FluticasoneFluticasone PropionateSeasonal Allergic RhinitisOcular SymptomAzelastine

Introduction

Two large paediatric studies are currently underway in the U.S. to investigate efficacy and safety of MP29-02 (Dymista) in children, with a view to extending its indication to those aged ≥6 yrs. In line with FDA recommendations, these studies compare MP29-02 to placebo. To mimic the clinical trial design of these on-going pediatric studies, this meta-analysis assessed all data available for moderate-to-severe SAR patients aged 12-17 years, who received either MP29-02 or placebo in the same vehicle and device.

Methods

Data from 4 multi-centre, parallel-group, randomized, double-blind, placebo-controlled, 14-day studies were pooled. A total of 97 patients aged 12-17 yrs received MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) 1 spray/nostril bid (total daily dose: AZE 548µg; FP 200µg) and 112 patients received placebo spray 1 spray/nostril bid. The primary efficacy variable was change from baseline over 14-days in reflective total nasal symptom score (rTNSS; AM +PM; MAX=24), the sum of 4 symptom scores for congestion, itching, rhinorrhoea and sneezing. Reflective total ocular symptom score (rTOSS; AM + PM; Max = 18) was an important secondary endpoint.

Results

Patients aged 12-17 yrs treated with MP29-02 experienced a 4.29 point mean improvement from baseline (18.7 [SD 2.7]) in their rTNSS, significantly more the 2.06 point improvement from baseline (18.7 [SD 2.8]) observed in those treated with placebo (diff: 2.23; 95% CI: 3.23; 1.22; p<0.0001). Similarly, in this adolescent patient population treatment with MP29-02 produced a significant mean improvement in the rTOSS of 2.23 points from baseline (11.2 [SD 4.4]) compared to 1.04 points from baseline (10.9 [SD 4.0]) with placebo (diff: 1.19; 95% CI: 2.06, 0.32; p=0.0080).

Conclusion

These results show that adolescent SAR patients treated with MP29-02 experience significant relief from both their nasal and ocular symptoms. Similar beneficial effects may be expected in pediatric patients.

Authors’ Affiliations

(1)
Suomen Terveystalo Allergy Clinic, Turku, Finland
(2)
Medscript, Dundalk, Ireland
(3)
Meda, Bad Homburg, Germany
(4)
University of Athens, Athens, Greece

Copyright

© Valovirta et al; licensee BioMed Central Ltd. 2014

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. 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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