Shah Shailen R, Nayak Anjuli, Ratner Paul, Roland Peter, Michael Wall G
Allergy and Asthma Consultants of NJ-PA, Collegeville, Pennsylvania, USA.
Clin Ther. 2009 Jan;31(1):99-107. doi: 10.1016/j.clinthera.2009.01.016.
Seasonal allergic rhinitis (SAR) is an allergen-induced inflammatory reaction that occurs during periods of high pollen count. Current treatments for SAR include allergen avoidance, systemic antihistamines, and steroidal and nonsteroidal intranasal sprays. Olopatadine is a selective antihistamine and an inhibitor of proinflammatory mediators from human mast cells. An intranasal formulation of olopatadine has been developed for the treatment of SAR.
The aim of this study was to compare the efficacy and tolerability of olopatadine hydrochloride nasal spray 0.6% (OLO) relative to azelastine hydrochloride nasal spray 0.1% (AZE) and an inactive vehicle in the treatment of SAR.
This Phase III, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group study was conducted at 21 centers across the United States. Eligible patients were aged > or =12 years and had a history of SAR and verified allergy to a prevalent local allergen. After a run-in period during which inactive vehicle was administered, patients were randomly assigned to OLO, AZE (active control), or inactive vehicle (identical to OLO; placebo control), 2 sprays in each nostril BID for 16 days. The timing of enrollment was correlated with the start of the allergy season at each site. Symptoms were recorded twice daily in an electronic diary. Efficacy assessments included changes in mean daily reflective total nasal symptom scores (TNSS). Tolerability was evaluated based on adverse events (AEs) and nasal, physical, and cardiovascular parameters.
A total of 544 patients were randomized. The mean age was 36 years (range, 12-77 years); men and boys represented 32.2% of the population; and the patients were predominantly white (75.4%). The mean reductions from baseline in reflective TNSS were 26.8%, 29.9%, and 18.4% with OLO, AZE, and inactive vehicle, respectively (P = 0.003 OLO vs inactive vehicle; 95% CI, -2.5% to 8.7% OLO vs AZE [non-inferiority]). The most commonly reported treatment-related AE in the OLO and AZE groups was bitter taste (12.2% [22/180] and 19.7% [37/188], respectively). The prevalence and intensity of bitter taste were significantly lower with OLO than with AZE (P = 0.05 and P = 0.005, respectively). In the group that received inactive vehicle, the prevalence of bitter taste was 1.7% (3/176). The prevalences of other treatment-related AEs, including epistaxis and nasal discomfort, were < or =3.7% in each group and did not differ significantly between groups.
In this small study in patients aged > or =12 years with SAR, the percentage reduction from baseline in TNSS was significantly greater with OLO (2 sprays in each nostril BID) compared with vehicle and not significantly different from that with AZE. OLO and AZE were similarly well tolerated, with the exception of prevalence and intensity of bitter taste, which were significantly lower with OLO.
季节性变应性鼻炎（SAR）是一种在花粉计数高峰期发生的变应原诱导的炎症反应。目前SAR的治疗方法包括避免接触变应原、全身使用抗组胺药以及使用甾体和非甾体鼻喷雾剂。奥洛他定是一种选择性抗组胺药，也是人肥大细胞促炎介质的抑制剂。已开发出一种奥洛他定鼻内制剂用于治疗SAR。
本研究旨在比较0.6%盐酸奥洛他定鼻喷雾剂（OLO）相对于0.1%盐酸氮卓斯汀鼻喷雾剂（AZE）和一种无活性赋形剂治疗SAR的疗效和耐受性。
这项III期、多中心、随机、双盲、活性药物和安慰剂对照的平行组研究在美国21个中心进行。符合条件的患者年龄≥12岁，有SAR病史且经证实对当地一种常见变应原过敏。在给予无活性赋形剂的导入期后，患者被随机分配至OLO组、AZE组（活性对照）或无活性赋形剂组（与OLO相同；安慰剂对照），每侧鼻孔喷2次，每日2次，共16天。入组时间与各研究地点过敏季节的开始时间相关。症状通过电子日记每天记录两次。疗效评估包括每日平均反射性总鼻症状评分（TNSS）的变化。根据不良事件（AE）以及鼻、身体和心血管参数评估耐受性。
共有544例患者被随机分组。平均年龄为36岁（范围12 - 77岁）；男性和男孩占总人群的32.2%；患者主要为白人（75.4%）。OLO组、AZE组和无活性赋形剂组反射性TNSS较基线的平均降低率分别为26.8%、29.9%和18.4%（OLO组与无活性赋形剂组比较，P = 0.003；OLO组与AZE组比较，95%CI为 - 2.5%至8.7%[非劣效性]）。OLO组和AZE组最常报告的与治疗相关的AE是苦味（分别为12.2%[22/180]和19.7%[37/188]）。OLO组苦味的发生率和强度显著低于AZE组（分别为P = 0.05和P = 0.005）。在接受无活性赋形剂的组中，苦味的发生率为1.7%（3/176）。其他与治疗相关的AE（包括鼻出血和鼻部不适）在每组中的发生率≤3.7%，且组间无显著差异。
在这项针对年龄≥12岁的SAR患者的小型研究中，与赋形剂相比，OLO组（每侧鼻孔喷2次，每日2次）TNSS较基线的降低百分比显著更大，且与AZE组无显著差异。OLO和AZE的耐受性相似，但苦味的发生率和强度OLO组显著更低。
