Volume 5 Supplement 4
A new allergic rhinitis therapy (MP29-02*) provides nasal and ocular symptom relief days faster than current firstline monotherapies
© Hellings et al. 2015
Published: 26 June 2015
The efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in providing overall nasal and ocular symptom relief vs AZE, FP or placebo (PLA) has been assessed.
Six hundred and ten moderate-to-severe SAR patients (≥12 yrs) were randomized into a double-blind, PLA-controlled, 14-day, parallel-group, trial (NCT00660517) to MP29-02*, AZE, FP or PLA nasal sprays (1 spray/nostril bd; daily dose: AZE=548μg; FP=200μg) . Change from baseline (CFB) in reflective total of 7 symptom scores (rT7SS; AM + PM, max=42) was assessed post-hoc. CFB in rT7SS and each nasal (congestion, itching, rhinorrhea, sneezing) and ocular symptom (itching, redness, watering; max=6 each) was assessed over time.
Overall, MP29-02* patients showed greater reduction in rT7SS vs FP, AZE & PLA (relative diff: 52% to FP (p=0.0013), 56% to AZE (p=0.0004)) evident from treatment day 1 vs FP (p=0.0072), AZE (p=0.0336) or PLA (p<0.0001) and sustained for 14 days. The level of relief achieved by MP29-02* patients on Day 2 (-5.52) was not achieved before Day 5 by FP patients or Day 8 by AZE patients. This pattern of rapid, sustained and superior symptom relief by MP29-02* was observed for each nasal and ocular symptom, which was not the case with FP and AZE. MP29-02* provided significantly superior nasal congestion relief than FP or AZE from Day 2; the level of congestion relief provided by MP29-02* on Day 2 (-0.77) was not achieved before Day 6 and Day 9 for FP and AZE, respectively. MP29-02* provided significantly superior ocular itching relief vs FP from Day 2 and vs AZE from Day 3; the ocular itch relief provided by MP29-02* on Day 2 (-0.77) was not achieved before Day 10 for FP-patients. Similarly, the level of ocular itch relief provided by MP29-02* on Day 3 (-1.06) was not achieved by AZE-patients before Day 11.
The consistent and rapid effect in alleviating all nasal and ocular symptoms is unique to MP29-02* and contributes to its superiority over AZE and FP. The time advantage over firstline therapy in achieving significant relief and sustained effect should improve patient concordance. MP29-02* is considered a new standard of care in AR.
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.