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 patients’ 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 MP29-02’s wide therapeutic spectrum and assert its consistent superiority over an intranasal corticosteroid.
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 patients’ 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 MP29-02’s wide therapeutic spectrum and assert its consistent superiority over an intranasal corticosteroid.
| Original language | English |
|---|---|
| Pages (from-to) | 495-503 |
| Number of pages | 9 |
| Journal | Journal of Investigational Allergology and Clinical Immunology |
| Volume | 23 |
| Issue number | 7 |
| Publication status | Published - 2 Jul 2013 |
Bibliographical note
AcknowledgementsWe thank Dr Ruth Murray (MedScript, Ireland) for assistance in editing and reviewing this manuscript.
Funding
This study was funded by Meda Pharma.
Keywords
- Dymista
- Chronic rhinitis
- Fluticasone propionate
- Perennial allergic rhinitis
- Long-term
- Efficacy
- Symptom-free days
- Responder analysis