Volume 5 Supplement 4
A new allergic rhinitis therapy (MP29-02*) provides effective and rapid symptom relief for patients who suffer most from the bothersome symptoms of nasal congestion or ocular itch
© Fokkens et al. 2015
Published: 26 June 2015
Allergic rhinitis (AR) patients often present with a predominant symptom. Nasal congestion and ocular symptoms have the greatest negative impact on patients’ quality of life . Our aim was to assess the efficacy of MP29-02* (a novel intranasal formulation of azelastine hydrochloride [AZE] and fluticasone propionate [FP] in an advanced delivery system) in seasonal AR (SAR) patients presenting with nasal congestion or ocular itch predominantly compared to AZE, FP or placebo (PLA) nasal sprays.
610 patients (≥12 yrs old) with moderate/severe SAR were randomized into a double-blind, PLA-controlled, 14-day, parallel-group trial to MP29-02*, AZE FP or PLA nasal sprays (all 1 spray/nostril bid [total daily doses: AZE 548μg; FP 200μg]). Patients were categorized as nasal congestion- or ocular itch-predominant (for those patients with baseline rTOSS ≥ 8) according to maximal symptom scores at baseline. Targeted symptom reduction was assessed for each predominant symptom over the entire 14 day period and on each day.
Congestion-predominant MP29-02*-patients experienced 3 times the congestion relief of FP-patients (p=0.0018) and 5 times the relief provided by AZE (p=0.0001). AZE and FP did not significantly differ from PLA. Superior congestion relief afforded by MP29-02* in these patients was evident from Day 2 vs FP (p=0.0155), AZE (p=0.0032) and PLA (p=0.0010) and sustained for 14 days. The level of relief achieved by MP29-02* patients on Day 2 (-0.90) was not achieved before Day 9 by either FP or AZE patients. Ocular itch predominant MP29-02*-patients experienced 4 times the ocular itch relief as FP-patients (p=0.0026) and twice the relief provided by AZE (p=0.0551). FP did not provide additional ocular itch relief over the placebo response. The level of ocular itch relief achieved by MP29-02* patients on Day 2 (-0.93) was not achieved before Day 9 by FP patients or before Day 4 by AZE patients.
Unlike currently available first line therapy, MP29-02* effectively and rapidly reduced nasal congestion and ocular itch in patients suffering predominantly from these symptoms. MP29-02*’s rapidity and effectiveness in relieving predominant congestion and ocular itch could lead to a reduction in the need for concomitant decongestants and eye drops, respectively and further supports the position of MP29-02* as the drug of choice for the treatment of 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.