The BASA Study: Breath Analysis for Severe Asthma Patients. A New, Non-invasive Approach for the Monitoring of Inflammation in Severe Asthma Patients on Biologics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
研究概览
简要总结
This study will evaluate the fluctuations of exhaled breath markers in patients with severe asthma on biologics. In the study, severe asthma patients will be followed up to 16 weeks monitoring lung function and inflammation through non-invasive technologies such as exhaled breath analysis (FeNO, GC-MS and EBC). A control group will be followed up to two weeks with the overall objective to indentify and evaluate the modifcations of markers of inflammation in patient under biologic treatment.
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
- 是
入选标准
- •Severe asthma diagnosis according to the latest recommendation
- •Eligible or in treatment with a biologic treatment for severe asthma
- •Able to follow istructions
- •Able and willing to sign the informed consent
排除标准
- •Not able to perform lung function measurements and the procedures of the study
- •Acute respiratory or non respiratory infection (<4 weeks)
- •Not willing to continue the study
结局指标
主要结局
evaluate the fluctuations of markers of inflammation in patients with severe asthma under biologic therapy
时间窗: 16 weeks
次要结局
- evaluate whether the measurement of H2O2 could be considered as a marker of inflammation in severe asthma patients(16 weeks)
研究者
Stefania Principe
MD, PhD
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
