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Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Maastricht University Medical Center

Brief Summary:

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

Detailed 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:

  1. 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.
  2. 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.
  3. 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.

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Study Type : Observational
Estimated Enrollment : 255 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
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
cystic fibrosis
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

Primary Outcome Measures :
  1. Study I: concentration of inflammatory markers in EB(C) [ Time Frame: 1 week ]
  2. Study II: Reproducibility of inflammatory markers in EB(C) [ Time Frame: 1 week ]
  3. Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways [ Time Frame: 1 week ]

Biospecimen Retention:   Samples Without DNA
Exhaled breath condensate. Exhaled breath.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
For study I and II: community sample For study III: healthy children recruited at a primary school, children with asthma, cystic fibrosis, chronic lung disease or pneumonia, recruited from the outpatient clinic of pediatric pulmonology

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00983671

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Contact: M.D. Ottink, MD +31-43-3877248
Contact: E. Dompeling, Phd +31-43-3877248

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Maastricht University Medical Centre, Pediatric Pulmonology Recruiting
Maastricht, Po Box 5800, Netherlands, 6202 AZ
Principal Investigator: M.D. Ottink, MD         
Sponsors and Collaborators
Maastricht University Medical Center
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Study Director: E. Dompeling, PhD Maastricht University Medical Centre
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Responsible Party: Drs. M.D. Ottink, Fellow pediatric pulmonology, Pediatric Pulmonology, dept. of Pediatrics, University Hospital Maastricht Identifier: NCT00983671    
Other Study ID Numbers: MEC 09-2-080
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011
Keywords provided by Maastricht University Medical Center:
cystic fibrosis
chronic lung disease
bronchopulmonary dysplasia
Additional relevant MeSH terms:
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Cystic Fibrosis
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases