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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.
Full description
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:
Study design:
Part I: Cross-sectional study assessing the random influence of presence or absence of various factors on the concentration of IM in EB(C); Part II: A short-term prospective study on reproducibility during five consecutive days; Part III: A cross-sectional comparative study in several groups of children (healthy, asthma, CF, PCD, BPD, LRTI);
Study population:
Study part I and II are performed in healthy adult volunteers. Study part III is performed in healthy children and in children with asthma, CF, PCD, BPD, and LRTI aged 2-16 years.
Primary study parameters/outcome of the study:
Study part I: Concentration of IM in EB(C). Study part II: Reproducibility as assessed by coefficients of variations of IM in EB(C).
Study part III: Concentration of IM in EB(C) from more distal and more proximal airways.
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Inclusion criteria
study part I and II:
Exclusion criteria
Study part I and II:
Study part III:
255 participants in 4 patient groups
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Central trial contact
M.D. Ottink, MD; E. Dompeling, Phd
Data sourced from clinicaltrials.gov
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