Standardisation of Measurements in Exhaled Breath and Exhaled Breath Condensate.

NCT00983671 | Unknown

• 2 other identifiers: MEC 09-2-080NL25969.068.09
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Cystic Fibrosis; Chronic Lung Disease; Pneumonia

Keywords

Asthma; cystic fibrosis; chronic lung disease; bronchopulmonary dysplasia; pneumonia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre, Pediatric Pulmonology

Maastricht, Po Box 5800, 6202 AZ, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath condensate. Exhaled breath.

MeSH Terms

Conditions

Asthma; Cystic Fibrosis; Pneumonia; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Respiratory Tract Infections; Infections; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases

Study Officials

• E. Dompeling, PhD

  Maastricht University Medical Centre

  STUDY DIRECTOR

Central Study Contacts

M.D. Ottink, MD

CONTACT

+31-43-3877248; m.ottink@mumc.nl

E. Dompeling, Phd

CONTACT

+31-43-3877248; edward.dompeling@mumc.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 24, 2009
• Study Start: February 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

NL (1)