Non-Invasive Biomarkers in Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Cystic Fibrosis Foundation
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00413140
First received: December 18, 2006
Last updated: NA
Last verified: November 2003
History: No changes posted
  Purpose

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®.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment: 100
Study Start Date: June 2004
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   5 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00413140

Locations
Netherlands
Catharina Hospital
Eindhoven, Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
St Radboud Childrens Hospital
Nijmegen, Netherlands
Máxima Medical Centre
Veldhoven, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
AstraZeneca
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Charlotte M Robroeks, M 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

No publications provided

ClinicalTrials.gov Identifier: NCT00413140     History of Changes
Other Study ID Numbers: MEC 03-228-CF
Study First Received: December 18, 2006
Last Updated: December 18, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
childhood disease
cystic fibrosis
exhaled breath condensate
exhaled nitric oxide
airway inflammation
non-invasive inflammatory markers
controls
children

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014