NCT00404976

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
Last Updated

November 29, 2006

Status Verified

November 1, 2003

First QC Date

November 28, 2006

Last Update Submit

November 28, 2006

Conditions

AsthmaHealthyChildren

Keywords

inflammometryexhaled breath condensatefractional exhaled nitric oxideasthmachildren

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Charlotte M Robroeks, MD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Edward Dompeling, MD, PhD

    Maastricht University Medical Center

    STUDY DIRECTOR

  • Quirijn Jöbsis, MD, PhD

    Maastricht University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

June 1, 2004

Study Completion

April 1, 2005

Last Updated

November 29, 2006

Record last verified: 2003-11

Locations

NL(1)