Evaluation of Response to Monoclonal Antibody Therapy in Severe Asthma: Research of Predictive Biomarkers in Exhaled Air
试验速览
- 阶段
- 不适用
- 发起方
- Hopital Foch
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response
研究概览
简要总结
This study evaluates the change in the composition of Volatil Organic Compounds (VOC) in patients treated by monoclonal antibody for severe asthma.
详细描述
At least one in two patients treated by monoclonal antibody for severe asthma doesn't have satisfying result after 6 months of treatment.
The evaluation of the answer, and even better the answer prediction, are fundamental issues for medico-economic plan as part of these innovative therapeutics.
The interest of the use of VOC as diagnostic or prognostic tool in patients with tumoral thoracic pathology or bronchial or pulmonary vascular diseases has been demonstrated.
VOC analysis will be performed using two different techniques: electronic nose and masse spectrometry. At each visit, in addition to the usual assessment, patients will have two non-invasives collections of exhaled air, one for electronic nose analysis and one for masse spectrometry analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient aged > 18 years old
- •patient with severe asthma who respond to the indication of monoclonal antibody therapy according to SPC and management criteria fixed by Transparency Committee
- •signed informed consent
- •patient with healthcare insurance
排除标准
- •patient not responding to the criteria for the good use of monoclonal antibody in severe asthma
- •contraindication to one of monoclonal antibody treatment according to SPC (hypersensitivity to one of compounds)
- •patient unable to perform a slow vital capacity
- •patient with long-term oxygen therapy , under invasive ventilation
- •pregnant women
- •patient deprived of liberty by judicial or administrative decision
结局指标
主要结局
Change of Volatil Organic Compound (VOC) profiles predictive of clinically significant response
时间窗: 1 day
Clinically significant response defined by: * reduction of 50% of number of exacerbations treated by oral corticosteroids after 12 months of treatment compared to the number of exacerbation during the previous year AND/OR * increase of 3 points (MCID according to Schartz and al 2009) of ACT score after 3 months of treatment and maintained at 6 months
次要结局
- Decrease of residual volume(change from baseline profiles at 3, 6 and12 months post-baseline)
- Volatil Organic Compound (VOC) profiles according to patients' phenotype(1 day)
- Change of FEV and FEV/CV(change from baseline profiles at 3, 6 and12 months post-baseline)
- Change before and after treatment(change from baseline profiles at 12 months post-baseline)
- Decrease of the daily dose of oral corticosteroids(change from baseline profiles at 1, 3, 6 and12 months post-baseline)
- Reduction in the number of exacerbations(change from baseline profiles at 1, 3, 6 and12 months post-baseline)
- Change according to administered antibody(1 day)