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Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00404976
First received: November 28, 2006
Last updated: NA
Last verified: November 2003
History: No changes posted
  Purpose

Background:

Exhaled nitric oxide and inflammatory biomarkers in exhaled breath condensate may be useful to diagnose and monitor childhood asthma. Their ability to indicate an asthma diagnosis, and to assess asthma severity and control, is largely unknown.

Objective:

To study 1) the ability of exhaled nitric oxide and inflammatory markers in exhaled breath condensate (nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10, acidity) to discriminate between childhood asthma and controls. 2) the ability of these biomarkers to indicate asthma severity and control.

Methods:

114 Children were included: 64 asthmatics (10.7±3.0 years, 67.2% atopic) and 50 controls (10.0±0.4 years). Condensate was collected using a glass condenser


Condition
Asthma
Healthy
Children

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Biomarkers in Exhaled Breath (Condensate) Indicate Presence, Severity and Control of Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Asthmatic and control children, aged 5 to 16 years
  • Children with doctor-diagnosed asthma, known at the department of Paediatric Pulmonology, University Hospital Maastricht

Exclusion Criteria:

  • Presence of a disease that might interfere with the results of this study (e.g. recent upper airway infection, heart disease, anatomic abnormalities of the airways and other chronic inflammatory diseases such as Crohns disease and rheumatoid arthritis)
  • Mental retardation
  • Inability to perform the EBC procedure properly
  • Active smoking
  • The use of one of the following medication: Papaverin, Sodium nitroprusside, ACE inhibitors, Oxymetazoline, L-arginine, or NOS inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00404976

Locations
Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
Sponsors and Collaborators
Maastricht University Medical Center
AstraZeneca
Investigators
Principal Investigator: Charlotte M Robroeks, MD Maastricht University Medical Center
Study Director: Edward Dompeling, MD, PhD Maastricht University Medical Center
Study Director: Quirijn Jöbsis, MD, PhD Maastricht University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00404976     History of Changes
Other Study ID Numbers: MEC 03-228
Study First Received: November 28, 2006
Last Updated: November 28, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
inflammometry
exhaled breath condensate
fractional exhaled nitric oxide
asthma
children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013