跳至主要内容
临床试验/NCT05946421
NCT05946421招募中不适用

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

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月4日最近更新:
适应症

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

发起方
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefania Principe

MD, PhD

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

研究点 (1)

Loading locations...

相似试验