Non-Invasive Biomarkers in Cystic Fibrosis
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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 Time Perspective: Prospective |
| Official Title: | Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis |
Eligibility| Ages Eligible for Study: | 5 Years to 25 Years |
| Genders Eligible for Study: | Both |
| 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:
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| Netherlands | |
| Catharina Hospital | |
| Eindhoven, Netherlands | |
| University Hospital Maastricht | |
| Maastricht, Netherlands, 6202AZ | |
| St Radboud Childrens Hospital | |
| Nijmegen, Netherlands | |
| Máxima Medical Centre | |
| Veldhoven, Netherlands | |
| 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 May 16, 2013