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首页> 外文期刊>Clinical and Translational Allergy >MP29-02*’s advanced delivery system contributes to its efficacy in patients with moderate/severe seasonal allergic rhinitis
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MP29-02*’s advanced delivery system contributes to its efficacy in patients with moderate/severe seasonal allergic rhinitis

机译：MP29-02 *的先进输送系统有助于中度/重度季节性变应性鼻炎患者的疗效

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BackgroundFour previously published trials assessed the efficacy ofMP29-02* (a novel intranasal formulation of azelastinehydrochloride (AZE) and fluticasone propionate (FP) in anadvanced delivery system) in seasonal allergic rhinitis(SAR) [1,2]. The first study compared MP29-02* to marketedAZE and FP [2]. The others compared MP29-02* toAZE and FP in the MP29-02* vehicle and delivery device(i.e. re-formulated comparators) [1]. FP contained withinMP29-02* has a unique PK fingerprint [3]. The aim of thisanalysis was to demonstrate that formulation/device contributeto MP29-02*’s clinical efficacy.MethodsFour thousand and five moderate/severe SAR patients(≥12 yrs old) were randomized into 4 double-blind, placebo(PLA)-controlled trials. Each trial comprised 4 groups:MP29-02*, AZE, FP and PLA nasal sprays, and was conductedfor 14 days. Total daily dose of AZE and FP were548 μg and 200 μg, respectively. Change from baseline(CFB) in reflective total nasal symptom score (rTNSS)over 14-days was the primary outcome. CFB in reflectivetotal ocular symptom score (rTOSS) and individual nasaland ocular symptoms was assessed secondarily. Time toachieve at least a 50% rTNSS reduction from baseline wasassessed post-hoc by Kaplan Meier estimates and log ranktests. The formulation/device effect of MP29-02* wasquantified by comparing treatment differences obtainedwith MP29-02* vs marketed FP and MP29-02* vs reformulatedFP for these endpoints.ResultsFor all efficacy variables assessed, the treatment differencewas greater for MP29-02* vs marketed-FP than for MP29-02* vs re-formulated-FP. For rTNSS, the differencebetween MP29-02* and marketed-FP was -1.47, comparedto -0.76 vs reformulated-FP; a formulation/device effect of0.71. Similarly for rTOSS a formulation/device effect of0.70 was observed. A formulation/device effect wasobserved for relief of all individual nasal and ocular symptoms(e.g. 0.23 effect for congestion; 0.34 effect for ocularitching). Finally, MP29-02*-patients achieved a ≥50%rTNSS reduction ≤6 days faster than marketed-FP and ≤3days faster than reformulated-FP, a formulation/deviceeffect of ≤3 days.ConclusionFormulation and device contribute to MP29-02*’s superiorefficacy over currently considered firstline therapy, makingMP29-02* a new class of treatment for AR.
机译：背景先前已发表的四项试验评估了MP29-02 *（一种新型的鼻内注射盐酸氮卓斯汀和丙酸氟替卡松在鼻腔给药系统中的新药）在季节性变应性鼻炎（SAR）中的疗效[1,2]。第一项研究将MP29-02 *与marketedAZE和FP进行了比较[2]。其他人则将MP29-02 *车辆和运输设备（即重新配制的比较器）中的MP29-02 *与AZE和FP进行了比较[1]。 MP29-02 *中包含的FP具有唯一的PK指纹[3]。该研究的目的是证明该制剂/装置有助于MP29-02 *的临床疗效。方法将4千5百名中度/重度SAR患者（≥12岁）随机分为4名双盲，安慰剂（PLA）对照审判。每个试验包括4组：MP29-02 *，AZE，FP和PLA鼻喷雾剂，进行了14天。 AZE和FP的每日总剂量分别为548μg和200μg。主要的结果是超过14天的总鼻反射症状评分（rTNSS）从基线（CFB）的变化。其次评估CFB的反射性总眼症状评分（rTOSS）和个别的nasaland眼症状。卡普兰·迈耶（Kaplan Meier）估计和对数秩检验评估了事后评估从基线至少达到rTNSS降低50％的时间。通过比较MP29-02 *与市售FP和MP29-02 *与重新配制的FP在这些终点上获得的治疗差异，量化了MP29-02 *的配方/装置效果。与重新配制的FP相比，市售的FP比MP29-02 *更便宜。对于rTNSS，MP29-02 *和市售FP之间的差异为-1.47，相比于重新配制的FP为-0.76;配方/装置效应为0.71。类似地，对于rTOSS，观察到0.70的制剂/装置效应。观察到制剂/装置的效果可减轻所有个体的鼻和眼症状（例如，充血的效果为0.23;眼跳的效果为0.34）。最后，MP29-02 *患者的rTNSS降低≥50％，比市售FP快≤6天，比重新配方FP快≤3天，结论≤3天。结论配方和设备对MP29-02 *有贡献与目前考虑的一线治疗相比，MP29具有更高的疗效，使MP29-02 *成为AR的新型治疗方法。

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