Type 2 Innate Lymphoid Cells in Severe Pediatric Asthma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of type 2 innate lymphoid cells
研究概览
简要总结
The main objectives of this study are to show that the number of type 2 innate lymphoid cells (ILC2) of the bronchial mucosa and in bronchoalveolar lavages (BAL) are higher in asthmatic children than in non-asthmatics, that the number of ILC2 of the bronchial mucosa and in BAL correlate with the number of bronchial and BAL eosinophils, and to determine whether there is a correlation between plasma and bronchial and BAL ILC2.
详细描述
Severe asthma of the child is characterized by chronic eosinophilic infiltration of the bronchial mucosa associated with bronchial remodeling.
The mechanisms responsible for these phenomena are still misunderstood. Animal models suggest that type 2 innate lymphoid cells (ILC2) may be responsible for inflammation and bronchial remodeling in asthma. In mice, ILC2 stimulated by the pulmonary epithelium by viral aggression or allergenic exposure release cytokines of the TH2 type such as IL-5 and IL-13 and amphiregulin, involved in the recruitment and differentiation of eosinophils, bronchoconstriction, mucus secretion and the restoration of epithelial integrity.
In humans, ILC2 would be more abundant in the bronchoalveolar lavage (BAL) and peripheral blood of asthmatic patients compared to control subjects. However, the presence of ILC2 in the bronchial mucosa of asthmatic patients has never been identified.
The hypothesis tested is that ILC2 are more abundant in bronchial mucosa, BAL, and blood in children with severe asthma than in non-asthmatics. The results of this study would improve the knowledge of the mechanisms responsible for bronchial inflammation in asthma, consider therapies to prevent its development and modify the natural history of the disease.
The main objectives of this study are to show that the number of ILC2 in bronchial mucosa and BAL is higher in asthmatic children than in non-asthmatics, that the number of ILC2 in the bronchial mucosa and BAL is correlated with the number of eosinophils in bronchial mucosa and BAL, to determine whether the number of ILC2 in lungs correlate with asthma symptoms, and to determine whether there is a correlation between plasma and bronchial ILC2.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minors aged 6 to 18 matched in age with severe asthmatic children
- •Non-asthmatic children hospitalized in the department of pediatric pulmonology and allergy in Necker Hospital
- •To undergo bronchial endoscopy with bronchoalveolar lavage, biopsy and blood collection
- •Severe asthmatic children :
- •Minors aged 6 to 18
- •Children hospitalized in the department of pediatric pulmonology and allergy in Necker Hospital
- •To undergo bronchial endoscopy with bronchoalveolar lavage, biopsy and blood collection
- •Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene
排除标准
- •Children with an immune deficiency, will be excluded
研究组 & 干预措施
Asthmatic children
Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene
干预措施: Biopsy (Biological)
Asthmatic children
Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene
干预措施: Blood collection (Biological)
Asthmatic children
Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene
干预措施: Bronchoalveolar lavage (Biological)
Controls
Non-asthmatic children, paired in age, requiring bronchial endoscopy with BAL and bronchial mucosa biopsy.
干预措施: Biopsy (Biological)
Controls
Non-asthmatic children, paired in age, requiring bronchial endoscopy with BAL and bronchial mucosa biopsy.
干预措施: Blood collection (Biological)
Controls
Non-asthmatic children, paired in age, requiring bronchial endoscopy with BAL and bronchial mucosa biopsy.
干预措施: Bronchoalveolar lavage (Biological)
结局指标
主要结局
Number of type 2 innate lymphoid cells
时间窗: Day 0
Type 2 innate lymphoid cells
次要结局
- Number of Eosinophils(Day 0)
- Airway remodeling: airway smooth muscle area(Day 0)
- Airway remodeling: epithelial integrity(Day 0)
- Metabolomic signature(Day 0)
- Airway remodeling: reticular basement membrane thickness(Day 0)
- Airway remodeling: mucus gland area(Day 0)
- Airway inflammation: bronchoalveolar lavage (BAL)(Day 0)
- Airway remodeling: vessel number(Day 0)
- Airway inflammation: bronchial mucosa(Day 0)
- Inflammation in blood(Day 0)
- Microbiota analysis(Day 0)