Asthma Clinical Trial
Official title:
The Feasibility and Diagnostic Value of New Point-of-care Instruments for Breath Analysis in Children With Asthma, Cystic Fibrosis (CF), and Healthy Controls
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.
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.
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