跳至主要内容
临床试验/NCT04520165
NCT04520165进行中(未招募)不适用

Effect of Anti-IL5 and Anti-IgE on Alternative Functions of Eosinophils in Severe Asthma

University of Liege1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
52
试验地点
1
主要终点
Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not

研究概览

简要总结

The investigators will measure different cytokines in the sputum (interleukin ((IL))-3, granulocyte-macrophage colony-stimulating factor ((GM-CSF)), IL5, IL-13, IL-33, IL-4, IL-25 thymic stromal lymphopoietin ((TSLP)) and eotaxin-1 ) and in the blood to evaluate their ability to predict the response after 6 months and 1 year of treatment with a biologic treatment (anti-IgE, anti-IL5, anti-IL5R) in terms of reduction in exacerbations and corticosteroid use, improvement in Forced expiratory volume in the first second (FEV1) (+200ml), in asthma control (ACQ decrease >0.5, ACT increase >3), in asthma quality of life (increase in AQLQ score > 0.5) and the effect on sputum and blood inflammation.

详细描述

Severe asthma is observed in 3 to 5% of the asthmatic population and is characterized by a higher rate of exacerbations, poorly controlled asthma and/or a poor lung function. During the last ten years, anti- Immunoglobulin E (IgE) and anti-IL5 (and anti-IL5R) have considerably improved severe asthma status. Treatment with chronic or oral course of corticosteroids is indeed responsible for a lot of side effects. There is however a lack of biomarkers for the prediction of responders to anti-IL5 and anti-IgE.

The investigators have previously found that sputum eosinophil counts are good predictors for improvement in lung function of severe asthmatics using anti-IL5. Sputum cells might not be the only relevant sputum marker for responders to biologics.

The objective is to evaluate the ability of sputum cytokines (protein levels and genes) (IL-3, IL-4, IL-5, IL-13, IL-33 and GM-CSF) to predict the response of severe asthmatics after 6 months and 1 year of treatment with biologics in terms of reduction in exacerbations and corticosteroid use, improvement in FEV1, in asthma control, in asthma quality of life and the effect on sputum and blood inflammation.

Severe asthmatics seen in the Asthma Clinic of CHU of Liege are very well characterized using baseline measure of blood samples, induced sputum, lung function, fractional exhaled nitric oxide (FeNO), asthma control questionnaires (ACT - ACQ) and asthma quality of life questionnaires (AQLQ).

Data on exacerbations during the previous year and current inhaled and oral treatment is also recorded. If FEV1 value is upper than 70% of the predicted value, severe asthmatics also perform a methacholine challenge to evaluate bronchial hyperresponsiveness.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Severe asthmatics seen in the Asthma Clinic of CHU of Liege who agree to undergo complete visit at baseline and after 6 months and 1 year of treatment with a biologic and sign informed consent.

排除标准

  • 未提供

结局指标

主要结局

Presence of Prognostic Markers of Remission in the Sputum Cell Compartment or Not

时间窗: 1 year follow-up

Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers of remission in the sputum cell profile were investigated.

Presence of Prognostic Markers (Mediators) of Remission in the Sputum or Not

时间窗: 1 year follow-up

Remission was defined as patients combining after the instauration of the biotherapy: no oral corticosteroids, no exacerbation, ACQ lower than 1.5 and/or asthma control test (ACT) greater than 19 and, a FEV1 greater or equal to 80% predicted and/or an improvement of FEV1 greater or equal to 10% and a blood eosinophil count lower than 300 cells/microliter. Markers ( inflammatory mediators) of remission in the sputum were investigated.

次要结局

  • is EPX in the Sputum of Prognostic Marker of ACT Improvement in the Sputum or Not ?(1 year follow-up)
  • Is IL-5 in the Sputum a Prognosis Marker for Improvement of FEV1 Post-treatment or Not ?(1 year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Renaud Louis

Professor

University of Liege

研究点 (1)

Loading locations...

相似试验