Optimising and Standardising Measurements of Inflammatory Markers in Exhaled Breath (EB) and Exhaled Breath Condensate (EBC)
试验速览
- 阶段
- 不适用
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Study I: concentration of inflammatory markers in EB(C)
研究概览
简要总结
Background: in various pediatric pulmonary diseases such as asthma, cystic fibrosis or bronchopulmonary dysplasia an increased inflammation is present. Measuring this inflammation is often hardly possible and requires invasive techniques such as bronchoscopy.
With the use of exhaled breath condensate (EBC) or exhaled breath (EB) analysis it is possible to measure the inflammation in an non-invasive way. However, there is a great need to further standardise these measurements and to identify possible confounding factors.
详细描述
Background of the study:
Measurement of inflammatory markers (IM) in exhaled breath and exhaled breath condensate (EB(C)) is a very interesting and useful non-invasive new technique to evaluate airway inflammation. This technique is helpful for diagnostic and monitoring purposes in both children and adults with chronic lung disease. The hypothesis of the present study is that standardisation not only increase the reproducibility of measurements but will also enlarge the possibility to detect differences between healthy and diseased subjects.
Objective of the study:
- to investigate the influence of various factors on the concentration of markers in EB(C); parameters on a subject level (e.g. breathing pattern, nose clip, inspiratory filter, saliva contamination, physical exertion), on an apparatus level (cleaning procedures, temperature of the condenser tube, environmental conditions, buffer bags), and on a measurement/analysis level (sampling time, storage time, storage temperature, protein inhibitor or bovine serum albumine) can be discriminated.
- to assess whether the reproducibility of measurements in EB(C) can be increased by analysing with ellipsometry, lyophilization or by standardising for exhaled volume, sampling time, or dilution factor.
- to investigate whether differences in inflammatory markers (IM) in EBC between healthy and diseased subjects will increase by specific EB(C) sampling from more distal airways. Children with asthma, cystic fibrosis (CF), primary ciliary dyskinesia (PCD), bronchopulmonary dysplasia (BPD), and lower respiratory tract infections (LRTI) will be included.
Study design:
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
- 是
入选标准
- •study part I and II:
- •healthy adults, 18-50 years study part III:
- •healthy children age 6-18 years
- •patients with cystic fibrosis
- •patients with asthma
- •patients with chronic lung disease
- •patients with pneumonia, all age 6-18 years
排除标准
- •Study part I and II:
- •Subjects with a history of atopy or respiratory disease, as indicated by the ISAAC questionnaire.
- •Study part III:
- •Mental retardation
- •active smoking
- •heart disease
- •syndromes
- •congenital malformations of the airways
- •inability to perform the measurements
- •for patients with lower respiratory tract infection: oxygen need, asthma or other chronic lung disease, active or passive smoking, inability to perform the measurements.
结局指标
主要结局
Study I: concentration of inflammatory markers in EB(C)
时间窗: 1 week
Study II: Reproducibility of inflammatory markers in EB(C)
时间窗: 1 week
Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways
时间窗: 1 week
次要结局
未报告次要终点