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临床试验/NCT05476484
NCT05476484已完成不适用

Long-term Real World-effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets in Subjects With Allergic Rhinitis With or Without Asthma: Results From a Multinational, Retrospective Register Study

ALK-Abelló A/S1 个研究点 分布在 1 个国家目标入组 46,196 人开始时间: 2022年4月1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
46,196
试验地点
1
主要终点
Symptom-relieving medication use for allergic rhinitis

研究概览

简要总结

To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.

详细描述

Allergic rhinitis (AR) is an inflammatory disorder, characterised by pruritus, sneezing, rhinorrhoea, and nasal congestion. It is one of the most common disorders worldwide, with an estimated global prevalence of 10-30%. AR is a chronic and progressive disease, as the underlying respiratory allergy can progress into allergic asthma. The prevalence of asthma in patients with AR is high and estimated between 10-40%. The presence of AR commonly exacerbates asthma, increasing the risk of asthma exacerbations, emergency visits and hospitalisations for asthma.

Recently, the high-quality retrospective cohort REACT study (ClinicalTrial.gov: NCT04125888) found that allergy immunotherapy (AIT) was associated with long-term reduction in AR medication use as well as significant reductions in both controller and reliever asthma medication and concurrent lower risk of asthma exacerbation and pneumonia in subjects with pre-existing asthma. The SQ sublingual immunotherapy (SLIT)-tablets have robust evidence from randomised controlled trials (RCTs), but real-world evidence (RWE) is needed to complement the findings from RCTs by looking at e.g. longer time horizons and broader patient populations. As the REACT study was not designed to specifically look at evidence-based AIT treatments like the SQ SLIT-tablets, the real-world effectiveness of SQ SLIT tablets remain to be further elucidated.

研究设计

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

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AR-patients identified by having at least two dispensations of prescribed AR medications for two consecutive years and/or ICD10-codes of AR in specialty care
  • For the SQ SLIT-tablet cohort:
  • - at least 2 dispensations within 365 days of SQ SLIT-tablets (ATC: V01AA02 and V01AA03)
  • For the control cohort:
  • - unexposed subjects will be identified from the study population of AR-patients that may be eligible to receive SQ SLIT-tablets, but have not dispensed a prescription of SQ SLIT-tablets during the index year of the case or prior to that year

排除标准

  • - Any allergy immunotherapy treatment prior to the index event

研究组 & 干预措施

Allergic rhinitis patients with and without asthma treated with SQ SLIT-tablet

干预措施: SQ SLIT-tablet (Drug)

结局指标

主要结局

Symptom-relieving medication use for allergic rhinitis

时间窗: From pre-index to follow-up year(s), assessed from 2005 and up to 2021

Overall number of prescriptions and by individual drug classes (prescribed products containing INCS or prescribed antihistamines )

次要结局

  • Medication use for asthma(From pre-index to follow-up year(s), assessed from 2005 and up to 2021)
  • Lower airway infections assessed by prescriptions of antibiotics and diagnosis codes for pneumonia(From pre-index to follow-up year(s), assessed from 2005 and up to 2021)
  • Asthma disease severity assessed by reliever and controller medication prescriptions and hospitalisations due to asthma(From pre-index to follow-up year(s), assessed from 2005 and up to 2021)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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