Rhinitis, sinusitis, and upper airway diseaseA novel intranasal therapy of azelastine with fluticasone for the treatment of allergic rhinitis
Section snippets
Protocol
Individual results and a meta-analysis of 3 phase III, multicenter, randomized, double-blind, parallel-group trials (MP4002 [NCT00651118], MP4004 [NCT00740792], and MP4006 [NCT00883168]) were assessed in patients with moderate-to-severe SAR to determine the efficacy of MP29-02 compared with intranasal H1-antihistamine (azelastine), corticosteroid (FP), and placebo using the same formulation. Placebo spray comprised exactly the same vehicle/formulation as the active treatments without any active
Patients
Study completion rates were high (approximately 95%) and similar across studies and across treatment groups (see Table E2 in this article’s Online Repository at www.jacionline.org). Dropout rates were negligible (see Table E3 in this article’s Online Repository at www.jacionline.org). When data were pooled for meta-analysis, 848, 846, 847, and 857 patients received MP29-02, FP, azelastine, and placebo, respectively. The baseline characteristics of the 4 treatment groups were similar, both
Discussion
Before MP29-02, no clinical development program had demonstrated additional benefit over 2 currently recommended first-line AR therapies in patients with moderate-to-severe disease. In the present program MP29-02 demonstrated superior efficacy over intranasal FP and intranasal azelastine monotherapy in patients with AR in a set of 3 randomized, double-blind, placebo-controlled clinical studies with active controls by using the same device and formulation. This provides sound clinical evidence,
References (27)
- et al.
The diagnosis and management of rhinitis: an updated practice parameter
J Allergy Clin Immunol
(2008) - et al.
Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: case-control study
J Allergy Clin Immunol
(2007) - et al.
The economic impact of allergic rhinitis and current guidelines for treatment
Ann Allergy Asthma Immunol
(2011) - et al.
Economic burden of rhinitis in managed care: a retrospective claims data analysis
Ann Allergy Asthma Immunol
(2008) - et al.
Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision
J Allergy Clin Immunol
(2010) - et al.
Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis
Ann Allergy Asthma Immunol
(2008) - et al.
Keys to successful management of patients with allergic rhinitis: focus on patient confidence, compliance, and satisfaction
Otolaryngol Head Neck Surg
(2007) - et al.
Double-blind, placebo-controlled study of azelastine and fluticasone in a single nasal spray delivery device
Ann Allergy Asthma Immunol
(2010) - et al.
Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen)
Allergy
(2008) - et al.
A survey of the burden of allergic rhinitis in Europe
Allergy
(2007)
Rhinitis and its impact on work
Curr Opin Allergy Clin Immunol
Costs associated with persistent allergic rhinitis are reduced by levocetirizine
Allergy
Undertreatment of rhinitis symptoms in Europe: findings from a cross-sectional questionnaire survey
Allergy
Cited by (0)
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).
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.