Non-Invasive Biomarkers in Cystic Fibrosis

NCT00413140 | Completed

• 1 other identifier: MEC 03-228-CF
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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 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®.

Conditions

Cystic Fibrosis

Keywords

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

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• AstraZeneca: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (4)

Catharina Hospital

Eindhoven, Netherlands

Location

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

Location

St Radboud Childrens Hospital

Nijmegen, Netherlands

Location

Máxima Medical Centre

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Charlotte M Robroeks, M

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Edward Dompeling, MD, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

• Quirijn Jöbsis, MD, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: June 1, 2004
• Study Completion: May 1, 2005
• Last Updated: December 19, 2006

Record last verified: 2003-11

Locations

NL (4)