Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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.

Official Title
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Optimising and Standardising Measurements of Inflammatory Markers in Exhaled Breath (EB) and Exhaled Breath Condensate (EBC)

Conditions
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Asthma, Cystic Fibrosis, Chronic Lung Disease, Pneumonia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| children with asthma<br>children with diagnosed asthma, age 6-18 years | |
| cystic fibrosis<br>children with cystic fibrosis, age 6-18 years | |
| chronic lung disease<br>children with chronic lung disease, also known as bronchopulmonary dysplasia, age 6-18 years | |
| pneumonia<br>children with clinical signs of pneumonia, age 6-18 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study I: concentration of inflammatory markers in EB(C) |  | 1 week | 
| Study II: Reproducibility of inflammatory markers in EB(C) |  | 1 week | 
| Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, cystic fibrosis, chronic lung disease, bronchopulmonary dysplasia, pneumonia