盐酸氮卓斯汀 0.15% 鼻腔喷雾剂在环境暴露室中治疗过敏性鼻炎的起效时间。

IF 5.8 2区医学 Q1 ALLERGY

Annals of Allergy Asthma & Immunology Pub Date : 2024-12-01 DOI:10.1016/j.anai.2024.07.020

Shu-Ning Hsu PhD , Fatima Sajjad PharmD , Elizabeth Brigham BA , Robert Centofanti MS , Robert An PhD , Patricia Couroux MD , Charlene Ng PhD

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引用次数: 0

摘要

背景：阿泽拉斯汀鼻喷雾剂可有效缓解季节性和常年性过敏性鼻炎症状：阿折拉斯汀鼻腔喷雾剂能有效缓解季节性和常年性过敏性鼻炎的症状：这项单中心、双盲、安慰剂对照、交叉研究的目的是评估盐酸阿折拉斯汀 0.15%与安慰剂对季节性过敏性鼻炎患者的起效时间。方法：110 名年龄在 18 岁至 65 岁之间的患者在环境暴露室（EEC）中持续暴露于豚草花粉后，随机接受盐酸阿折拉斯汀 0.15%与安慰剂鼻腔喷雾剂，每个鼻孔各喷洒两次。症状通过鼻腔症状总分（TNSS）量表进行主观评估。主要疗效参数是阿折拉斯汀的起效时间，以给药后 15、30、45、60、90、120、180 和 240 分钟 TNSS 与基线相比的变化来衡量：结果：与安慰剂相比，阿折拉斯汀鼻喷雾剂组在用药后 30 分钟的 TNSS 有统计学意义上的显著改善（p=0.0002），并且这种效果在随后所有时间点的 EEC 疗程中都持续存在（p结论：阿折拉斯汀鼻喷雾剂组在用药后 30 分钟的 TNSS 有统计学意义上的显著改善（p=0.0002）：盐酸氮卓斯汀 0.15%鼻喷雾剂可缓解过敏性鼻炎相关的鼻部症状，并在 30 分钟内快速起效。阿折拉斯汀的总体安全性也已得到证实。这些研究结果以及之前关于过敏性鼻炎患者疗效和生活质量改善的研究结果，确立了盐酸阿司汀 0.15%的重要临床作用。

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Onset of efficacy of azelastine hydrochloride 0.15% nasal spray for allergic rhinitis in an environmental exposure chamber

Background

Azelastine nasal spray is effective in relieving symptoms of seasonal and perennial allergic rhinitis.

Objective

To evaluate the time to onset of efficacy of azelastine hydrochloride (HCl) 0.15% vs placebo in participants with seasonal allergic rhinitis.

Methods

A total of 110 participants aged 18 to 65 years were randomized to receive azelastine HCl 0.15% 2 sprays per nostril vs placebo nasal spray after being continuously exposed to ragweed pollen in an environmental exposure chamber. Symptoms were evaluated subjectively by the total nasal symptom score (TNSS) scale. The primary efficacy parameter was the time to onset of efficacy of azelastine as measured by the change from baseline in TNSS 15, 30, 45, 60, 90, 120, 180, and 240 minutes post-dose.

Results

The azelastine nasal spray group had statistically significant improvement in TNSS compared with placebo 30 minutes post-dose (P = .0002), and the effect was sustainable throughout the environmental exposure chamber session for all subsequent time points (P < .0001). Adverse events were mild, including bitter taste, nasal discomfort, epistaxis, sinusitis, and nausea. No major adverse events were reported during the study.

Conclusion

Azelastine HCl 0.15% nasal spray relieves nasal symptoms associated with allergic rhinitis and has a fast onset of action within 30 minutes. The overall safety profile of azelastine has also been proven to be safe. These results, along with previous findings on efficacy and improved quality of life for people with allergic rhinitis, establish the important clinical role of azelastine HCl 0.15%.

Trial Registration

ClinicalTrials.gov Identifier: NCT04264637.

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来源期刊

Annals of Allergy Asthma & Immunology 医学-过敏

CiteScore

6.50

自引率

6.80%

发文量

437

审稿时长

33 days

期刊介绍： Annals of Allergy, Asthma & Immunology is a scholarly medical journal published monthly by the American College of Allergy, Asthma & Immunology. The purpose of Annals is to serve as an objective evidence-based forum for the allergy/immunology specialist to keep up to date on current clinical science (both research and practice-based) in the fields of allergy, asthma, and immunology. The emphasis of the journal will be to provide clinical and research information that is readily applicable to both the clinician and the researcher. Each issue of the Annals shall also provide opportunities to participate in accredited continuing medical education activities to enhance overall clinical proficiency.