MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: A randomized, double-blind, placebo-controlled trial of efficacy and safety
MP29-02 (a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate) in the treatment of seasonal allergic rhinitis: A randomized, double-blind, placebo-controlled trial of efficacy and safety
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DOI：
10.2500/aap.2012.33.3587
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发表时间：
2012-07-01
影响因子：
2.8
通讯作者：
Carr, Warner
中科院分区：
文献类型：
--
作者：
Meltzer, Eli O.;LaForce, Craig;Carr, Warner
尽管有可用的治疗方案，许多过敏性鼻炎 (AR) 患者的症状仍不受控制。本研究旨在评估 MP29-02（一种由丙酸氟替卡松 [FP] 和盐酸氮卓斯汀 [AZ] 组成的新型鼻内制剂）与 FP、AZ 和安慰剂喷雾剂单一疗法治疗季节性过敏性鼻炎 (SAR) 的疗效和安全性。这项为期 2 周的随机、双盲、安慰剂对照试验在 779 名中度至重度 SAR 患者中进行。治疗采用相同的载体和递送装置，每天两次，每次1次喷雾/鼻孔。 AZ和FP的每日剂量分别为548微克和200微克。主要功效变量是 12 小时反射性总鼻症状评分 (rTNSS)，包括鼻塞、打喷嚏、鼻痒和流鼻涕。次要功效变量是 (1) 12 小时个体鼻部症状反思评分； (2) 起效； (3) 12小时反射性总眼部症状评分(rTOSS)，包括眼痒、流泪、眼红等； (4)鼻结膜炎生活质量问卷(RQLQ)总分。与 FP（-4.55；p = 0.038）、AZ（-4.54；p = 0.032）和安慰剂（-3.03；p < 0.001）相比，MP29-02 使平均 rTNSS 较基线显着降低了 -5.54 点，使 rTNSS 比 FP 的贡献提高了 39%。所有个体鼻部症状均有助于 MP29-02 的功效。 30 分钟内起效。与安慰剂相比，MP29-02 显着改善了 rTOSS，在总体 RQLQ 评分方面提供了临床上重要的改善，并且耐受性良好。在这项研究中，MP29-02 比两种广泛使用的一线 AR 治疗方法能更彻底地缓解症状，并且耐受性良好。
Many patients with allergic rhinitis (AR) have uncontrolled symptoms despite available treatment options. This study was designed to evaluate the efficacy and safety of MP29-02 (a novel intranasal formulation of fluticasone propionate [FP] and azelastine [AZ] hydrochloride), compared with monotherapy with FP, AZ, and placebo sprays for the treatment of seasonal allergic rhinitis (SAR). This 2-week randomized, double-blind, placebo-controlled trial was conducted in 779 patients with moderate-to-severe SAR. Treatments were administered 1 spray/nostril twice daily in the same vehicle and delivery device. Daily doses of AZ and FP were 548 and 200 micrograms, respectively. The primary efficacy variable was the 12-hour reflective total nasal symptom score (rTNSS), consisting of nasal congestion, sneezing, itchy nose, and runny nose. Secondary efficacy variables were (1) 12-hour reflective individual nasal symptom scores; (2) onset of action; (3) 12-hour reflective total ocular symptom score (rTOSS), including itchy eyes, watery eyes, and red eyes; and (4) the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score. MP29-02 significantly reduced the mean rTNSS from baseline by -5.54 points compared with FP (-4.55; p = 0.038), AZ (-4.54; p = 0.032), and placebo (-3.03; p < 0.001), improving the rTNSS by 39% beyond the contribution of FP. All individual nasal symptoms contributed to the efficacy of MP29-02. Onset of action was within 30 minutes. MP29-02 significantly improved rTOSS compared with placebo, provided a clinically important improvement in the overall RQLQ score, and was well tolerated. In this study, MP29-02 provided more complete symptom relief than two widely used first-line AR treatments and was well tolerated.