Cystic FibrosisNCT00413140
Non-Invasive Biomarkers in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Maastricht University Medical Center at 4 sites in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 5 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 100 participants
- Where
- 4 sitesNetherlands
- Study dates
- Jun 2004to May 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Catharina Hospital
Eindhoven
University Hospital Maastricht
Maastricht, 6202AZ
St Radboud Childrens Hospital
Nijmegen
Máxima Medical Centre
Veldhoven
About this study
Official title: Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis
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
- Medical subject headings
- Cystic Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startJun 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Cystic Fibrosis Foundation
- Investigators
- Charlotte M Robroeks, M, Principal investigator, Maastricht University Medical CenterEdward Dompeling, MD, PhD, Study director, Maastricht University Medical CenterQuirijn Jöbsis, MD, PhD, Study director, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413140
- Sponsor's protocol ID
- MEC 03-228-CF
- Status last verified
- Nov 2003
- First submitted
- 18 Dec 2006
- Last updated
- 19 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Exhaled Breath Indicate Presence, Control and Severity of Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00413140
- Acronym / sponsor ID
- MEC 03-228-CF
- Conditions
- Cystic Fibrosis
- Keywords
- childhood disease, cystic fibrosis, exhaled breath condensate, exhaled nitric oxide, airway inflammation, non-invasive inflammatory markers, controls, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Cystic Fibrosis Foundation
- Study start
- Jun 2004
- Study completion
- May 2005
- First posted
- 19 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte M Robroeks, M principal investigator
Maastricht University Medical Center
Edward Dompeling, MD, PhD study director
Maastricht University Medical Center
Quirijn Jöbsis, MD, PhD study director
Maastricht University Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Maastricht University Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2006.