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CompletedNCT00413140Updated Dec 19, 2006

Non-Invasive Biomarkers in Cystic Fibrosis

An observational study in Cystic Fibrosis, sponsored by Maastricht University Medical Center. Completed at 4 sites in Netherlands. Open to participants aged 5 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2006-12-19.

Sponsored by Maastricht University Medical Center · Observational

Study type
Observational
Time perspective
Other
Enrollment
100
Ages
5 Years to 25 Years
Sex
All
01

Study summary

Background Chronic airway inflammation is present in cystic fibrosis. Non-invasive inflammometry may be useful in disease management.

Objective We studied 1) the ability of fractional exhaled nitric oxide and inflammatory markers (acidity, nitrite, nitrate, hydrogen peroxide, 8-isoprostane, interferon-γ, tumor necrosis factor-α, interleukin-2,-4,-5,-10) in exhaled breath condensate, to discriminate between cystic fibrosis and control children, and, 2) the relationship of biomarkers with control and severity of cystic fibrosis.

Methods In 98 children (48 cystic fibrosis / 50 controls), condensate was collected using a glass condenser. Exhaled nitric oxide was measured using the NIOX®.

02

Conditions studied

  • Cystic Fibrosis

Keywords

  • childhood disease
  • cystic fibrosis
  • exhaled breath condensate
  • exhaled nitric oxide
  • airway inflammation
  • non-invasive inflammatory markers
  • controls
  • children
03

In context

Cystic Fibrosis

1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.

This study's enrollment of 100 is above the median of 85 across 482 observational studies indexed under Cystic Fibrosis.

Browse Cystic Fibrosis studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

CF population

  • Children known with CF were recruited from the outpatient clinics. CF disease was defined as a combination of typical clinical features (e.g. persistent pulmonary problems, meconium ileus, failure to thrive, steatorrhoe) and an abnormal sweat test (Chloride > 60 mM). Uncontrolled CF was diagnosed by the paediatric pulmonologist based on a change in the presence or severity of respiratory symptoms in association with CF, and/or a decrease in lung function parameters compared to previous measurements during the last four weeks.

Control population

  • Control children without lung disease were recruited from the outpatient clinic of the University Hospital Maastricht. The reasons of consultation were constipation and enuresis nocturna. All children completed the 'International Study of Asthma and Allergies in Childhood (ISAAC) questionnaire to exclude children with any (history of) airway or allergy complaints, in order to exclude asthmatic disease

Exclusion criteria

Exclusion Criteria:

For both study populations:

  • Diseases that may interfere with the results of the study (e.g. 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 collection procedure
  • Active smoking
  • Use of the following medication: papaverin, sodium nitroprusside, angiotensin-converting enzyme (ACE) inhibitors, oxymetazoline, L-arginine, or nitric oxide synthase (NOS) inhibitors.
05

Study design

Time perspective
Other
Enrollment
100 participants
06

Study locations

4 sites
  • Catharina Hospital
    Eindhoven, Netherlands
  • University Hospital Maastricht
    Maastricht, 6202AZ, Netherlands
  • St Radboud Childrens Hospital
    Nijmegen, Netherlands
  • Máxima Medical Centre
    Veldhoven, Netherlands
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00413140
Lead sponsor
Maastricht University Medical Center
Collaborators
AstraZeneca, Cystic Fibrosis Foundation
First posted
Dec 19, 2006
Start date
Jun 2004
Completion
May 2005
Last update
Dec 19, 2006

Study contacts

Charlotte M Robroeks, M
principal investigator · Maastricht University Medical Center
Edward Dompeling, MD, PhD
study director · Maastricht University Medical Center
Quirijn Jöbsis, MD, PhD
study director · Maastricht University Medical Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2003. You cannot join it, but the record below documents what was studied.

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