A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis
Abstract
Background Moderate-to-severe allergic rhinitis (AR) is a challenge to treat, with many patients using multiple therapies and achieving limited symptom control. More effective therapies must be developed and tested in well-controlled, randomized, prospective studies with a direct comparison to current standards. Objectives The aim of these studies was to investigate the efficacy of MP29-02 (a novel formulation of azelastine and fluticasone propionate [FP]) in patients with moderate-to-severe seasonal allergic rhinitis (SAR) and to compare its efficacy with 2 first-line therapies (ie, intranasal azelastine and intranasal FP) in this population. Methods Three thousand three hundred ninety-eight patients (≥12 years old) with moderate-to-severe SAR were enrolled into 3 multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trials (MP4002 [NCT00651118], MP4004 [NCT00740792], and MP4006 [NCT00883168]). Each trial was conducted for 14 days during different allergy seasons. The primary efficacy variable was the sum of the morning and evening change from baseline in reflective total nasal symptom score (range, 0-24) over the treatment period. Outcomes for the meta-analysis included efficacy according to disease severity and time to response in relevant responder criteria. Results In the meta-analysis MP29-02 reduced the mean reflective total nasal symptom score from baseline (-5.7 [SD, 5.3]) more than FP (-5.1 [SD, 4.9], P Conclusions MP29-02 represents…
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The efficacy of MP-AzeFlu is superior to intranasal corticosteroids and intranasal H1 antihistamine monotherapy in patients with moderate-severe, poorly controlled allergic rhinitis or nonallergic rhinitis.
“The efficacy of MP-AzeFlu has been shown to be superior to INCs and intranasal anti-H 1 monotherapy in patients with moderate-severe, poorly controlled AR or NAR [148-150].”
From Position Paper on Nasal Obstruction: Evaluation and Treatment (2018) · cites this paper as [149]
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- Authors
- Carr, W., Bernstein, J., Lieberman, P., Meltzer, E., Bachert, C., Price, D., Munzel, U., & Bousquet, J.
- Affiliations
- University of Cincinnati (US)
- University of Tennessee Health Science Center (US)
- Allergy and Asthma Medical Group and Research Center (US)
- Ghent University Hospital (BE)
- University of Aberdeen (GB)
- Meda (Germany) (DE)
- Inserm (FR)
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2012-05
- Volume
- 129
- Issue
- 5
- Pages
- 1282-1289.e10
- ISSN
- 0091-6749 (ISSN-L)
- OpenAlex
- W2027093918
- Cited by
- 242
- References
- 2
- Citations by year
- 2026: 8 · 2025: 10 · 2024: 10 · 2023: 18 · 2022: 9 · 2021: 14 · 2020: 17 · 2019: 25 · 2018: 23 · 2017: 15 · 2016: 23 · 2015: 23 · 2014: 27 · 2013: 16 · 2012: 4
- FWCI
- 16.42
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion)
- Funders
- U.S. Department of Health and Human Services
- Amgen
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Teva Pharmaceutical Industries
- Genentech
- Topics
- Health Sciences › Medicine › Immunology and Allergy › Allergic Rhinitis and Sensitization
- Health Sciences › Medicine › Physiology › Asthma and respiratory diseases
- Health Sciences › Medicine › Otorhinolaryngology › Sinusitis and nasal conditions
- Keywords
- allergic rhinitis, azelastine, fluticasone propionate, intranasal therapy, combination therapy, nasal symptom score, time to response, drug efficacy comparison, first-line therapy, disease severity, allergy season
- MeSH terms
- Fluticasone, Administration, Intranasal, Adult, Androstadienes, Drug Combinations, Female, Rhinitis, Allergic, Seasonal, Humans, Male, Middle Aged, Phthalazines, Seasons, Severity of Illness Index, Nasal Obstruction, Guidelines as Topic, Disease Progression, Young Adult
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