The Feasibility and Diagnostic Value of New Point-of-care Instruments for Breath Analysis in Children With Asthma, Cystic Fibrosis (CF), and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events directly related to the various point-of-care tests used
研究概览
简要总结
In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.
详细描述
Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed non-invasive technique to assess airway inflammation. The non-invasive character makes it highly suitable for use in (preschool) children. However, the analysis of VOCs by gas chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion Mobility Spectrometer techniques) have been developed. However, these new point-of-care instruments have not been studied in children.
Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether these techniques can differentiate between healthy children, asthmatic children and children with Cystic Fibrosis (CF).
Study design: Cross-sectional study design. Several VOCs tests will be performed in all participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in exhaled breath condensate (EBC) will be measured.
Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.
Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility in children. For each technique, VOC profiles between study groups will be evaluated for its discriminative power.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 16 years
- •Healthy group: See exclusion criteria
- •Asthma group: Doctor's diagnosed asthma
- •Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis
- •Exclusion criteria
- •Recent course of prednisone or antibiotics (< 1 month before test)
- •Passive smoking
- •Other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease)
- •Healthy children:
- •No current or history of respiratory symptoms
- •No current or history of allergic rhinitis
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse events directly related to the various point-of-care tests used
时间窗: Questionnaire will be done directly after specific test (1 day). No long term (S)AE is expected and measurement of each test is only performed once.
Any adverse event of any kind will be noted. Furthermore, each participant will be asked whether the test was easy to perform. This question can be answered on a 5-point scale (0=totally agree that test was easy to perform, 4= totally disagree that test was easy to perform)
次要结局
- Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing asthma.(Measurements will be analysed within 6 to 12 months)
- Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing asthma.(Measurements will be analysed within 6 to 12 months)
- Sensitivity and Specificity of new point-of-care Aeonose eNose in diagnosing cystic fibrosis.(Measurements will be analysed within 6 to 12 months)
- Sensitivity and Specificity of Ion Mobility Spectrometry in diagnosing cystic fibrosis.(Measurements will be analysed within 6 to 12 months)