Inflammatory Markers in Exhaled Breath (Condensate) in Childhood Asthma

Healthy Clinical Trial

Official title:

Biomarkers in Exhaled Breath (Condensate) Indicate Presence, Severity and Control of Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404976
• Other study ID #: MEC 03-228
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: November 28, 2006
• Start date: June 2004
• Est. completion date: April 2005

Study information

• Verified date: November 2003
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma
• Children
• Healthy

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	AstraZeneca

Country where clinical trial is conducted

Netherlands,