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临床试验/NCT04125888
NCT04125888已完成不适用

Impact of AIT on Allergic Rhinitis and Asthma Using Real World Evidence

ALK-Abelló A/S1 个研究点 分布在 1 个国家目标入组 92,048 人开始时间: 2019年7月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
92,048
试验地点
1
主要终点
Allergic rhinitis medication use

研究概览

简要总结

The study will assess the effectiveness of AIT treatment in real clinical practice in Germany.

详细描述

Allergic rhinitis (AR) affects 23-30% of the European population and is associated with a major burden on public health. AR and asthma frequently coexist, and may both be caused by allergen exposure. While the efficacy of AIT, i.e. reduce symptoms and medication use in patients with AR and asthma, has been demonstrated in several randomized clinical trials, little is known about the use and effectiveness of AIT in real world clinical practice.

This study is a retrospective database study that uses real-world data from Germany. The study population consists of AR patients with and without asthma treated with AIT and matched controls not treated with AIT. Information about the patients and treatments will be obtained from the 'BKK German Sickness Fund Database' from 2007 until 2017.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • AIT prescription 12 months before the index event (in the pre-index period) for the AIT treatment group

研究组 & 干预措施

AIT Cohort

Allergic rhinitis patients with and without asthma treated with AIT

干预措施: Allergy immunotherapy (AIT) (Drug)

结局指标

主要结局

Allergic rhinitis medication use

时间窗: From pre-index year to follow-up year(s), assessed from 2007 and up to 2017

Number of patients with an AR prescription and number of prescriptions by drug class

次要结局

  • Asthma medication use(From pre-index to follow-up year(s), assessed from 2007 and up to 2017)
  • Change in asthma disease severity(From pre-index to follow-up year(s), assessed from 2007 and up to 2017)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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