Investigating Poor Response to Monoclonal Therapy in Asthma
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- An improvement in FEV1 as assessed by spirometry
研究概览
简要总结
Asthma affects 8% of the entire population. 4-5% of asthma sufferers have severe asthma, characterised by recurrent exacerbations (worsening of symptoms leading to the person having a bout of corticosteroids and/or antibiotics), significant symptoms and lack of response to the most widely used therapy, corticosteroids.
There is now new types of treatments (antibody drugs) which are licensed to manage severe asthma such as Anti-IL5. There is evidence Anti-IL5 and other similar antibody drugs are effective at reducing asthma exacerbations and reduce the need for oral corticosteroids for those that have severe asthma.
However, some patients respond poorly to Anti-IL5 and the investigators would like to find out why this happens. It is hoped that the investigators can identify the mechanism of poor treatment response to Anti-IL5. It is also hoped that the investigators can understand why symptoms worsen to the point of requiring antibiotics and/or steroids (also known as an exacerbation) for those prescribed Anti-IL5.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Severe asthma
Untreated by anti-IL5 treatment for severe asthma at point of recruitment. To be prescribed anti-IL5 as part of their treatment following consent. Note: Anti-IL5 treatment is prescribed as per agreed multidisciplinary team meeting, outside of the decision to enrol the patient on the study, and is administered by the clinical team as part of the patient's clinical care outside of the research study.
干预措施: Anti-IL5 Antibody (Drug)
Severe asthma
Untreated by anti-IL5 treatment for severe asthma at point of recruitment. To be prescribed anti-IL5 as part of their treatment following consent. Note: Anti-IL5 treatment is prescribed as per agreed multidisciplinary team meeting, outside of the decision to enrol the patient on the study, and is administered by the clinical team as part of the patient's clinical care outside of the research study.
干预措施: Bronchoscopy (Procedure)
Healthy control
Control group without respiratory condition
干预措施: Bronchoscopy (Procedure)
结局指标
主要结局
An improvement in FEV1 as assessed by spirometry
时间窗: 12 months
Treatment response as assessed as a clinically meaningful improvement in asthma control (ACQ change of \>0.5).
A clinically meaningful improvement in asthma control as assessed by ACQ
时间窗: 12 months
An improvement in FEV1 of \>100ml using spirometry.
Identification of mechanisms associated with poor response to anti-IL5 therapy
时间窗: 12 months
Identification of mechanisms associated with poor response to anti-IL5 therapy. A poor response is defined as an inability to halve the pre-treatment annualised exacerbation rate; an asthma exacerbation is defined as a worsening of asthma symptoms necessitating a short burst of oral corticosteroids, or a doubling of maintenance oral corticosteroid treatment dose.
次要结局
- The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via cytokine analysis(12 months)
- The identification of exacerbation pathogenesis in patients receiving anti-IL5 therapy via viral throat swab analysis(12 months)