Non-Invasive Biomarkers in Cystic Fibrosis

NCT ID: NCT00413140

Last Updated: 2006-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-05-31

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

Study Design

• Study Time Perspective: OTHER

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Charlotte M Robroeks, M

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Edward Dompeling, MD, PhD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Quirijn Jöbsis, MD, PhD

Role: STUDY_DIRECTOR

Maastricht University Medical Center

Locations

Catharina Hospital

Eindhoven, , Netherlands

University Hospital Maastricht

Maastricht, , Netherlands

St Radboud Childrens Hospital

Nijmegen, , Netherlands

Máxima Medical Centre

Veldhoven, , Netherlands

Countries

Netherlands

Other Identifiers

MEC 03-228-CF

Identifier Type: -

Identifier Source: org_study_id