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临床试验/NCT06261567
NCT06261567已完成不适用

A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service

AstraZeneca1 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2024年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
425
试验地点
1
主要终点
Number and proportion of responders

研究概览

简要总结

Asthma is a common lung condition that causes occasional breathing difficulties and affects around 5.4 million people in the UK of all ages. Common symptoms can include wheezing when breathing, breathlessness, a tight chest and coughing. However, these symptoms can get worse and lead to an asthma attack which can be fatal.

There is currently no cure for asthma but there are treatments that can help keep the symptoms under control. The main types of treatment include reliever inhalers used when needed quickly to reverse asthma symptoms for a short time, and preventer inhalers that are used everyday to prevent symptoms for starting. Unfortunately, not all patients are able to control their asthma on these treatments alone. Biologic treatments, also known as monoclonal antibodies, have been introduced to treat certain types of severe asthma over recent years. These specialist treatments use antibodies produced from cells in a laboratory to help reduce inflammation and might offer the possibility of higher levels of disease control including the reduction or absence of symptoms and normal lung function. This higher level of disease control is called remission.

This study aims to understand whether or not remission is possible in patients with severe asthmas treated with biologics in the NHS. This study will take place a 4 specialist asthma centres in the UK and seeks to include retrospective data from approximately 450 adult patients that were treated with biologics as part of routine care between 01 October 2021 and 30 September 2022. Data will be collected directly from medical records and entered into the study database in a pseudonymised format by members of the direct care team ready for analysis.

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
18 Years 至 130 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Initiated on a biologic treatment for SA between 1st October 2021 and 30th September 2022
  • Patients who received ≥1 dose of biologic treatment
  • Patients aged ≥18 years at index

排除标准

  • Patients who were involved in any interventional clinical trial during the study period (+/- 12 months from index).

结局指标

主要结局

Number and proportion of responders

时间窗: 12 months

Number and proportion achieving specific criteria for clinical remission

时间窗: 12 months

Number and proportion achieving the following criteria for clinical remission: * any 1 criterion * any 2 criteria * any 3 criteria * exacerbation AND maintenance oral corticosteroids (mOCS) criteria * exacerbation, mOCS, AND asthma symptom control criteria

Number and proportion of non-responders

时间窗: 12 months

Proportion of patients in clinical remission

时间窗: 12 months

Proportion of patients with zero exacerbations, zero mOCS use and ACQ \<1.5

Number and proportion of super-responders

时间窗: 12 months

次要结局

  • BMI(Index (first dose of biologic))
  • IMD quintile(Index (first dose of biologic))
  • Sex(Index (first dose of biologic))
  • Smoking status(Index (first dose of biologic))
  • Comorbidities(Index (first dose of biologic))
  • ACQ-6(Index (first dose of biologic))
  • AQLQ(Index (first dose of biologic))
  • Rate of exacerbation in prior 12 months(Index (first dose of biologic))
  • Age at index(Index (first dose of biologic))
  • Ethnicity(Index (first dose of biologic))
  • Annualised exacerbation rate (AER)(12 months)
  • mOCS use (proportion with 0 mg/day)(12 months)
  • COVID-19 vaccination status(Index (first dose of biologic))
  • Blood eosinophil count (EOS)(Index (first dose of biologic))
  • lung function (FEV1)(Index (first dose of biologic))
  • ACQ-6 score(12 months)
  • Fractional Exhaled Nitric Oxide (FeNO)(Index (first dose of biologic))
  • IgE(Index (first dose of biologic))
  • Asthma treatments at 6 months(6 months)
  • Asthma treatments at 12 months(12 months)
  • Lung function (FEV-1)(12 months)
  • AQLQ score(12 months)
  • Respiratory infections(12 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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