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Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00404976
First Posted: November 29, 2006
Last Update Posted: November 29, 2006
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.
Collaborator:
AstraZeneca
Information provided by:
Maastricht University Medical Center
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00404976     History of Changes
Other Study ID Numbers: MEC 03-228
First Submitted: November 28, 2006
First Posted: November 29, 2006
Last Update Posted: November 29, 2006
Last Verified: November 2003

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