Allergy and Asthma Consultants of NJ-PA, Collegeville, Pennsylvania, USA.
Allergy Asthma Proc. 2009 Nov-Dec;30(6):628-33. doi: 10.2500/aap.2009.30.3296. Epub 2009 Nov 19.
Azelastine is a second-generation antihistamine approved for treatment of allergic rhinitis. This randomized, double-blind, placebo- and active-controlled, parallel-group clinical trial evaluated the efficacy and safety of azelastine 0.15% and azelastine 0.10% nasal spray at a dosage of 2 sprays/nostril twice daily in patients with moderate-to-severe seasonal allergic rhinitis (SAR). In total, 526 patients were randomized 1:1:1 to treatment with 2 sprays/nostril twice daily of azelastine 0.15%, azelastine 0.10%, or placebo. The primary efficacy variable was change from baseline in 12-hour reflective Total Nasal Symptom Score (TNSS; A.M. and P.M. combined), consisting of nasal congestion, rhinorrhea, itchy nose, and sneezing. After 2 weeks, the mean improvement and percentage improvement in the 12-hour reflective TNSS were significant (p < 0.001) with azelastine 0.15% and azelastine 0.10% compared with placebo. In a retrospective analysis, there was a statistical difference (p = 0.047) in the mean improvement versus placebo in the 12-hour reflective TNSS with azelastine 0.15% compared with azelastine 0.10%. Onset of action with azelastine 0.15% was within 30 minutes. Bitter taste was the most common adverse event with both azelastine 0.15% and azelastine 0.10% (8.4% and 9.4% of patients, respectively). Somnolence was reported by 1.7% of patients treated with azelastine 0.15%, 0.6% of patients treated with azelastine 0.10%, and 0.6% of patients treated with placebo. Azelastine 0.15% nasal spray at 2 sprays/nostril twice daily significantly improved the nasal symptoms associated with SAR with an onset of action within 30 minutes and was well tolerated.
盐酸氮卓斯汀为第二代抗组胺药，适用于治疗过敏性鼻炎。本随机、双盲、安慰剂和阳性对照、平行分组临床试验评估了每日两次、每次每侧鼻腔喷 2 喷 0.15%和 0.10%盐酸氮卓斯汀鼻喷雾剂治疗中重度季节性过敏性鼻炎（SAR）患者的疗效和安全性。共有 526 例患者按 1:1:1 随机分为每日两次、每次每侧鼻腔喷 2 喷 0.15%盐酸氮卓斯汀、0.10%盐酸氮卓斯汀或安慰剂治疗。主要疗效变量为 12 小时反射性总鼻症状评分（TNSS；上午和下午合并）自基线的变化，包括鼻塞、流涕、鼻痒和打喷嚏。治疗 2 周后，0.15%盐酸氮卓斯汀和 0.10%盐酸氮卓斯汀组与安慰剂组相比，12 小时反射性 TNSS 评分的平均改善和百分比改善均具有显著统计学意义（p<0.001）。在回顾性分析中，与安慰剂相比，0.15%盐酸氮卓斯汀组 12 小时反射性 TNSS 评分的平均改善具有统计学差异（p=0.047）。0.15%盐酸氮卓斯汀起效时间在 30 分钟内。苦味是 0.15%盐酸氮卓斯汀和 0.10%盐酸氮卓斯汀最常见的不良事件（分别为 8.4%和 9.4%的患者）。使用 0.15%盐酸氮卓斯汀治疗的患者中有 1.7%报告出现嗜睡，使用 0.10%盐酸氮卓斯汀治疗的患者中有 0.6%报告出现嗜睡，使用安慰剂治疗的患者中有 0.6%报告出现嗜睡。每日两次、每次每侧鼻腔喷 2 喷 0.15%盐酸氮卓斯汀可显著改善 SAR 相关的鼻部症状，起效时间在 30 分钟内，且耐受性良好。
