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Sponsors and Collaborators: |
Maastricht University Medical Center AstraZeneca Cystic Fibrosis Foundation |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00413140 |
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 |
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Cystic Fibrosis |
Study Type: | Observational |
Study Design: | Screening, Cross-Sectional, Random Sample, Prospective Study |
Official Title: | Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis |
Ages Eligible for Study: | 5 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
CF population
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
Exclusion Criteria:
For both study populations:
Netherlands | |
University Hospital Maastricht | |
Maastricht, Netherlands, 6202AZ | |
Catharina Hospital | |
Eindhoven, Netherlands | |
Máxima Medical Centre | |
Veldhoven, Netherlands | |
St Radboud Childrens Hospital | |
Nijmegen, 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 |
Study ID Numbers: | MEC 03-228-CF |
Study First Received: | December 18, 2006 |
Last Updated: | December 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00413140 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
childhood disease cystic fibrosis exhaled breath condensate exhaled nitric oxide |
airway inflammation non-invasive inflammatory markers controls children |
Nitric Oxide Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Inflammation |
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |