Non-Invasive Biomarkers in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413140
• Other study ID #: MEC 03-228-CF
• Status: Completed
• Phase: N/A
• First received: December 18, 2006
• Last updated: December 18, 2006
• Start date: June 2004
• Est. completion date: May 2005

Study information

• Verified date: November 2003
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 25 Years

Eligibility

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.

Study Design

Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
Netherlands	Catharina Hospital	Eindhoven
Netherlands	University Hospital Maastricht	Maastricht
Netherlands	St Radboud Childrens Hospital	Nijmegen
Netherlands	Máxima Medical Centre	Veldhoven

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht University Medical Center	AstraZeneca, Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

Netherlands,