Clinical trial NCT00413140: Non-Invasive Biomarkers in Cystic Fibrosis
Official title: Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: childhood disease
cystic fibrosis
exhaled breath condensate
exhaled nitric oxide
airway inflammation
non-invasive inflammatory markers
controls
children
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Cystic Fibrosis Foundation
First posted: 2006-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

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®.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
city: Nijmegen
country: Netherlands
facility: St Radboud Childrens Hospital
city: Veldhoven
country: Netherlands
facility: Máxima Medical Centre
Study officials:
affiliation: Maastricht University Medical Center
name: Charlotte M Robroeks, M
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: Edward Dompeling, MD, PhD
role: STUDY_DIRECTOR
affiliation: Maastricht University Medical Center
name: Quirijn Jöbsis, MD, PhD
role: STUDY_DIRECTOR
References: