Anti-IL5 and Other Biotherapies in Cystic Fibrosis in French CF Centers : MAB-CF Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical evolution
研究概览
简要总结
Our project is to describe retrospectively and prospectively CF patients treated with biotherapy in French CF centers.
Main objective: To describe the clinical and paraclinical course of CF patients before and after treatment with anti-IL5 and other biotherapies since 2019.
Secondary objective: To describe adverse events potentially related to the biotherapies.
详细描述
•Background: ABPA and asthma associated with cystic fibrosis impact the CF course with a more rapid decline in lung function.
Corticosteroid therapy can be harmful and must be avoid in CF to prevent diabetes, osteoporomalacia or mycobacterium infections.
Monoclonal antibodies have the marketing authorization for severe uncontrolled asthma and, up to now, some CF patients with ABPA or severe asthma and high plasma IgE levels benefit from omalizumab.
Anti-Il5 agents are available since February 2019 and have demonstrated their efficacy in severe and hypereosinophilic asthma control (plasma eos.>300mmol/L).
Some patients with CF who have severe asthma or ABPA are still poorly controlled despite Omalizumab with other treatments (steroids and/or azoles). Some of them have persistent hypereosinophilia suggesting a possibility to treat with antiIL5 antibodies.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Clinical evolution
时间窗: 1 day
Physical examination (height in centimeters, weight in kilograms, numerical scales in score, temperature in degrees, SaO2 in percentage). Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis To assess the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Spirometry in liters or percentage evolution
时间窗: 1 day
Spirometry in liters or percentage Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
Biology evolution
时间窗: 1 day
Biology (leukocyte formula in 10\^9/L, IgE tot, IgE spe, sputum microbiology) Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
concomitant therapy evolution
时间窗: 1 day
concomitant therapy Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
CFQR and SNOT22 evolution
时间窗: 1 day
CFQR and SNOT22 questionnaires in score Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
exacerbation evolution
时间窗: 1 day
Defines the effectiveness of anti-inflammatory biotherapy in patients with cystic fibrosis
次要结局
- Number of any adverse event reported during biotherapy treatments(1 day)