Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.
|ClinicalTrials.gov Identifier: NCT00983671|
Recruitment Status : Unknown
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was: Recruiting
First Posted : September 24, 2009
Last Update Posted : July 22, 2011
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.
|Condition or disease|
|Asthma Cystic Fibrosis Chronic Lung Disease Pneumonia|
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.
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 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.
|Study Type :||Observational|
|Estimated Enrollment :||255 participants|
|Observational Model:||Case Control|
|Official Title:||Optimising and Standardising Measurements of Inflammatory Markers in Exhaled Breath (EB) and Exhaled Breath Condensate (EBC)|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
children with asthma
children with diagnosed asthma, age 6-18 years
children with cystic fibrosis, age 6-18 years
chronic lung disease
children with chronic lung disease, also known as bronchopulmonary dysplasia, age 6-18 years
children with clinical signs of pneumonia, age 6-18 years
- Study I: concentration of inflammatory markers in EB(C) [ Time Frame: 1 week ]
- Study II: Reproducibility of inflammatory markers in EB(C) [ Time Frame: 1 week ]
- Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways [ Time Frame: 1 week ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983671
|Contact: M.D. Ottink, MDfirstname.lastname@example.org|
|Contact: E. Dompeling, Phdemail@example.com|
|Maastricht University Medical Centre, Pediatric Pulmonology||Recruiting|
|Maastricht, Po Box 5800, Netherlands, 6202 AZ|
|Principal Investigator: M.D. Ottink, MD|
|Study Director:||E. Dompeling, PhD||Maastricht University Medical Centre|