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Original Article

 

A New Therapy (MP29-02) Is Effective for the Long-Term Treatment of Chronic Rhinitis

 

D Price,1 S Shah,2 S Bhatia,3 C Bachert,4 W Berger,5 J Bousquet,6 W Carr,5 P Hellings,7 U Munzel,8 G Scadding,9 P Lieberman10

1University of Aberdeen, Aberdeen, UK
2Allergy and Asthma Consultants of NJ-PA, Collegeville, Pennsylvania, USA
3IRL Clinical Research Centre, Mumbai, India
4Upper Airways Research Laboratory, Ghent University Hospital, Ghent, Belgium
5Allergy and Asthma Associates of Southern California, Mission Viejo, California, USA
6Hopital Arnaud de Villeneuve University Hospital, Montpellier and Inserm CESP1018, France
7University Hospitals Leuven, Leuven, Belgium
8MEDA Pharma GmbH & Co. KG, Bad Homburg, Germany
9The Royal National Throat Nose and Ear Hospital, London, UK
10University of Tennessee College of Medicine, Memphis, Tennessee, USA

J Investig Allergol Clin Immunol 2013; Vol. 23(7): 495-503

 

 Abstract


Background and objective: MP29-02 (Dymista), a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP), is significantly better than first-line therapy for the treatment of moderate-to-severe seasonal allergic rhinitis (SAR), and is well tolerated following 52 weeks of continuous use in chronic rhinitis. The aim of this study was to evaluate the long-term efficacy of MP29-02 versus FP in patients with chronic rhinitis.

Patients and methods: In total, 612 chronic rhinitis patients (perennial allergic rhinitis [PAR], n=424; nonallergic rhinitis, n=188) aged 12 years or older were enrolled into this open-label, parallel-group study and randomized to MP29-02 (1 spray/nostril bid) or FP nasal spray (2 sprays/nostril qd) for 52 weeks. Efficacy was assessed by change from baseline in PM reflective total nasal symptom score (rTNSS), time to first achieve 100% PM rTNSS reduction from baseline, and percentage of symptom-free days in the total and PAR populations posthoc.

Results: MP29-02 reduced patientsí PM rTNSS from baseline significantly more than FP, from Day 1 up to and including week 28 (-2.88 vs -2.53; P=.0048), with treatment difference maintained for 52 weeks. Fluctuation in significance after week 28 might be explained, at least in part, by decreasing sample size, permitted according to ICH guidelines. By Day 1 almost twice as many MP29-02-patients were symptom free. After 1 month, 71.1% of MP29-02 patients experienced 100% rTNSS reduction (60.3% for FP), and did on a median of 9 days faster (P=.0024). Over 52 weeks MP29-02 patients experienced 8.4% more symptom-free days (P=.0005). These results were mirrored in the PAR subpopulation.

Conclusion: These results confirm MP29-02ís wide therapeutic spectrum and assert its consistent superiority over an intranasal corticosteroid.

Key words: Dymista. Chronic rhinitis. Fluticasone propionate. Perennial allergic rhinitis. Long-term. Efficacy. Symptom-free days. Responder analysis.