MP29-02 Provides Rapid and More Complete Nasal Symptom Relief Than Two First-Line Therapies: A Retrospective Analysis of a Randomized, Double-Blind, Placebo-Controlled Trial

Journal of Allergy and Clinical Immunology(2013)

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摘要
In patients with moderate-to-severe SAR, it is an important goal of therapy to achieve a clinically relevant reduction in symptom severity. The reflective total nasal symptom score (rTNSS) has been the standard for evaluating changes in symptom severity in allergy clinical trials. As an additional analysis of the rTNSS, a criterion of ≤1 point remaining for each individual nasal symptom was developed. This criterion defines patients with a score of ‘0’ (none) or ‘1’ (mild) for each nasal symptom. 610 patients (≥12 years old) with moderate-to-severe SAR were randomized into a double-blind, 14-day, parallel-group trial of MP29-02 (Dymista™) compared to commercially-available azelastine nasal spray (AZ) or fluticasone propionate nasal spray (FP) and placebo (all administered as 1 spray/nostril bid; total daily doses: AZ=548 μg; FP=200 μg).1 Time to achieve ≤1 point remaining for each individual nasal symptom was assessed in a post-hoc analysis. 17.8% of MP29-02 patients achieved this response versus 8.3%, 9.2%, and 7.8% of those treated with AZ, FP, and placebo, respectively. MP29-02 patients achieved this response up to 7 days faster than AZ (p=0.0152) and up to 8 days faster than either FP (p=0.0262) or placebo (p=0.0094). Neither AZ nor FP differed from placebo. MP29-02 provided rapid and more complete symptom relief in patients with moderate-to-severe SAR than two first-line therapies. MP29-02 can be considered a treatment of choice for these patients.
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