Study of the Involvement of IL-17 / IL-22 Pathway in Bacterial Exacerbations of COPD
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Measure cytokines by ELISA
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a worldwide chronic inflammatory disease of the airways linked to environmental exposure. The chronic course of COPD is often interrupted by acute exacerbations which have a major impact on the morbidity and mortality of COPD patients. A bacterial etiology for these exacerbations is common (almost 50%). Moreover, airway bacterial colonization linked to an increased susceptibility is observed in COPD patients. Effective Th17 immune response is needed to develop a good response against bacteria. Thus, this study aims to demonstrate that there is a defective IL-17/ IL-22 response to bacteria in COPD leading to airway bacterial colonization and infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed COPD according GOLD guidelines
- •Current or ex-smoker (at least 10 pack-years)
- •Hospitalized for COPD exacerbation
排除标准
- •Asthma or Cystic fibrosis
- •No other chronic lung disease
- •Solid Tumor unhealed or not considered in remission
- •Inhaled drug consumption
- •Women of childbearing potential without effective contraception
- •Pregnant or breastfeeding women
- •Incapable of consent
- •Lack of social security coverage
研究组 & 干预措施
Bacterial exacerbations
Patients with at least 10^7 UFC/ml bacteria in their sputum during their first COPD exacerbation.
干预措施: Sample collecting (Other)
Bacterial exacerbations
Patients with at least 10^7 UFC/ml bacteria in their sputum during their first COPD exacerbation.
干预措施: Lung function measure (Other)
Non-bacterial exacerbations
Patients without detected bacteria or below 10^7 UFC/ml in sputum during their first COPD exacerbation.
干预措施: Sample collecting (Other)
Non-bacterial exacerbations
Patients without detected bacteria or below 10^7 UFC/ml in sputum during their first COPD exacerbation.
干预措施: Lung function measure (Other)
结局指标
主要结局
Measure cytokines by ELISA
时间窗: At inclusion (exacerbation) and between 8 to 16 weeks (steady-state)
Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the sputum,between the two groups of patients.
次要结局
- Quantification of immune cell types in the sputum(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Quantification of immune cell types in the blood(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Describe exacerbation phenotype(At inclusion (exacerbation))
- Describe environmental exposure(At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years)
- Analysis exercise tolerance(Between 8 to 16 weeks (steady-state) and at 2 and 4 years)
- Identify IL-17 and IL-22 producing cells in the blood(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Quantification of pro-inflammatory cytokines in blood(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Quantification of pro-inflammatory cytokines in sputum(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Compare sputum microbiota between exacerbation and steady-state(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Quantification of oxidative stress in exhaled condensates(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Identify IL-17 and IL-22 producing cells in the sputum(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Describe COPD treatments(At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years)
- Measure static lung function(Between 8 to 16 weeks (steady-state) and annually for 4 years)
- Measure airway resistances(Between 8 to 16 weeks (steady-state) and at 2 and 4 years)
- Compare the delta of IL-17 and IL-22 cytokines between exacerbation and steady-state in the blood.(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Identify pathogens linked to the exacerbation(At inclusion (exacerbation))
- Identify persistent pathogens at steady-state(Between 8 to 16 weeks (steady-state))
- Compare oxidative stress in the blood between exacerbation and steady-state(At inclusion (exacerbation) and between 8 to 16 weeks (steady-state))
- Describe COPD radiological phenotype(Between 8 to 16 weeks (steady-state))
- Describe COPD clinical phenotype(At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years)
- Quantify Quality of Life(At inclusion (exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years)
- Measure exercise tolerance(At inclusion (end of the hospitalization for exacerbation), between 8 to 16 weeks (steady-state) and annually for 4 years)