Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma - Full Text View

Sponsors and Collaborators:	Maastricht University Medical Center AstraZeneca
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00404976

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

MedlinePlus related topics: Asthma

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Random Sample, Prospective Study
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

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

Study ID Numbers:	MEC 03-228
Study First Received:	November 28, 2006
Last Updated:	November 28, 2006
ClinicalTrials.gov Identifier:	NCT00404976
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

Study placed in the following topic categories:

Nitric Oxide
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Healthy
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009