Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00983671
First received: September 17, 2009
Last updated: July 21, 2011
Last verified: July 2011
  Purpose

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
Asthma
Cystic Fibrosis
Chronic Lung Disease
Pneumonia

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Study I: concentration of inflammatory markers in EB(C) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Study II: Reproducibility of inflammatory markers in EB(C) [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Study III: concentration of inflammatory markers in EB(C) of the proximal and distal airways [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Exhaled breath condensate. Exhaled breath.


Estimated Enrollment: 255
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
pneumonia
children with clinical signs of pneumonia, age 6-18 years

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983671

Contacts
Contact: M.D. Ottink, MD +31-43-3877248 m.ottink@mumc.nl
Contact: E. Dompeling, Phd +31-43-3877248 edward.dompeling@mumc.nl

Locations
Netherlands
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
Investigators
Study Director: E. Dompeling, PhD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Drs. M.D. Ottink, Fellow pediatric pulmonology, Pediatric Pulmonology, dept. of Pediatrics, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00983671     History of Changes
Other Study ID Numbers: MEC 09-2-080, NL25969.068.09
Study First Received: September 17, 2009
Last Updated: July 21, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Asthma
cystic fibrosis
chronic lung disease
bronchopulmonary dysplasia
pneumonia

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pneumonia
Lung Diseases
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 16, 2014