Status:
COMPLETED
Non-Invasive Biomarkers in Cystic Fibrosis
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
AstraZeneca
Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5-25 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
OBSERVATIONAL
End Date :
May 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00413140
Start Date
June 1 2004
End Date
May 1 2005
Last Update
December 19 2006
Active Locations (4)
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1
Catharina Hospital
Eindhoven, Netherlands
2
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
3
St Radboud Childrens Hospital
Nijmegen, Netherlands
4
Máxima Medical Centre
Veldhoven, Netherlands