A novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis - 28/04/12
, Jonathan Bernstein, MD b, Phil Lieberman, MD c, Eli Meltzer, MD d, Claus Bachert, MD, PhD e, David Price, MD f, Ullrich Munzel, PD Dr rer nat g, Jean Bousquet, MD, PhD h
Corresponding author: Warner Carr, MD, Allergy and Asthma Associates of Southern California, 27800 Medical Center Rd, Suite 244, Mission Viejo, CA 92691.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 < .001), azelastine (−4.4 [SD, 4.8], P < .001), or placebo (−3.0 [SD, 4.2], P < .001). This benefit was observed from the first day of assessment, with improvement in each individual nasal symptom, even in the patients with the most severe disease. MP29-02 achieved response consistently days earlier and showed greater efficacy in patients with moderate-to-severe rhinitis than FP and azelastine.
Conclusions |
MP29-02 represents a novel therapy that demonstrated superiority to 2 first-line therapies for AR. Patients with moderate-to-severe SAR achieved better control, and their symptoms were controlled earlier with MP29-02 than with recommended medications according to guidelines.
Le texte complet de cet article est disponible en PDF.Key words : Allergic rhinitis, azelastine, fluticasone propionate, MP29-02, moderate-to-severe
Abbreviations used : ANCOVA, AR, FP, iTNSS, QoL, RQLQ, rTNSS, rTOSS, SAR
Plan
| These studies were funded by Meda Pharmaceuticals, Inc, and were designed to be consistent with recommendations provided in the US Food and Drug Administration guidance document for clinical development of drug products for allergic rhinitis (Guidance for Industry, US Department of Health and Human Services, US Food and Drug Administration Center for Drug Evaluation and Research; April 2000). |
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| Disclosure of potential conflict of interest: W. Carr has consulted for and received research support from MEDA, Alcon, and Ista. J. Bernstein has received research support from Meda and Dynova; is on the Board of Directors and a Fellow of the American Association of Allergy, Asthma & Immunology (AAAAI); is a Fellow at the American College of Allergy, Asthma & Immunology (ACAAI); and is Chairman of the Allergists for Israel (AFI). P. Lieberman is an advisor for the Allergy Foundation of America and Baxter and has given lectures for MEDA, Genentech, Ista, and TEVA. E. Meltzer has received research support from Amgen, Apotex, HRA, MedImmune, Schering-Plough, Alcon, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Proctor & Gamble, Sunovion (Sepracor), and Teva; is a consultant and/or is on the advisory board for Alcon, AstraZeneca, Bausch & Lomb, Dey, Forest, Ista, Johnson & Johnson, Meda, Merck, ONO Pharma, OptiNose, Proctor & Gamble, Rady Children’s Hospital, Rigel, Sanofi-Aventis, Sepracor, Stallergenes, Teva, Alexa, Boehringer Ingelheim, Kalypsys, and Sunovion; is a speaker for the AAAAI, Alcon, Allergists for Israel, Dey, Florida Allergy Asthma Immunology Society, Ista, Sepracor, Teva, Merck, and Sunovion; and has provided expert designation in legal matters for Aventis Pharmaceuticals and Sanofi Aventis v. Barr Laboratories, Fexofenadine. D. Price has received consultancy and speaker fees from Merck, Mundipharma, Novartis, Medapharma, Kyorin, and TEVA; has received consultancy fees from GlaxoSmithKline, Almirall, and Chiesi; has received consultancy fees and grants from Pfizer, and AstraZeneca; has received consultancy and speakers’ fees and grants from Boehringer Ingelheim; has received speakers’ fees and grants from Aerocrine; has received grants from the UK National Health Service, Nycomed, and Medapharma; is director of Research in Real Life Ltd; is a guideline group member for Allergic Rhinitis and its Impact on Asthma and EPOS; is a research committee member for International Primary Care Respiratory Group; and has shares in AKL Ltd. J. Bousquet has received honoraria from Stallergenes, Actelion, Almirall, AstraZeneca, Chiese, GlaxoSmithKline, Merck, Novartis, OM Pharma, Sanofi, TEVA, and Uriach. The rest of the authors declare that they have no relevant conflicts of interest. |
Vol 129 - N° 5
P. 1282 - mai 2012 Retour au numéro
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