Cystic FibrosisPREVECNCT01241890
Prevention of CF Exacerbation in Childhood: PREVEC Study
An observational study of Cystic Fibrosis and Children, run by Maastricht University Medical Center at 3 sites in Netherlands.
Trial summary
Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cystic Fibrosis, Children, Exhaled Breath Condensate
- How many people
- 49 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2011to Jul 2014
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Cystic Fibrosis
Who may be able to join
- CF disease is defined as the combination of:
- characteristic clinical features (persistent pulmonary symptoms, meconium ileus, failure to thrive, steatorrhoea);
- and/or abnormal sweat test (Chloride > 60mM);
- and/or two CF mutations.
Who cannot join
- cardiac abnormalities;
- mental retardation;
- no technical satisfactory performance of measurements;
- on the waiting list for lung transplantation;
- non-compliance with the home-assessments;
- patients with Burkholderia Cepacia;
- participation in another intervention trial.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Academic Medical Centre
Amsterdam
Maastricht University Medical Centre
Maastricht
University Medical Centre
Utrecht
About this study
Official title: Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)
Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.
- Conditions
- Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home Monitoring
- Keywords
- Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home monitoring, Quality of life
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cystic Fibrosis, care as usual | Treatment according to the Dutch Central Guidance Committee (CBO) guidelines for CF. Assessments: home monitoring, symptoms, lung function, quality of life and diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations
Definition of an exacerbation according to Treggiari MM et al.
Measured: 1 year
Secondary outcomes (1)
Quality of life
Quality of life questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startOct 2011
- Primary completionAug 2013
- Study completionJul 2014
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NCFS, Chiesie Pharmaceuticals B.V.
- Responsible party
- Sponsor
- Investigators
- E Dompeling, PhD MD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241890
- Sponsor's protocol ID
- MEC 11-3-111
- Acronym
- PREVEC
- Status last verified
- Jul 2015
- First submitted
- 15 Nov 2010
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of CF Exacerbation in Childhood (PREVEC): Early Recognition of Inflammation by Non-invasive Biomarkers in Exhaled Breath (Condensate)
- ClinicalTrials.gov ID
- NCT01241890
- Acronym / sponsor ID
- PREVEC / MEC 11-3-111
- Conditions
- Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home Monitoring
- Keywords
- Cystic Fibrosis, Children, Exhaled Breath Condensate, Non-invasive Inflammatory Markers, Volatile Organic Compounds, Home monitoring, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- NCFS, Chiesie Pharmaceuticals B.V.
- Study start
- Oct 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 16 Nov 2010 (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.
Pulmonary exacerbations of CF are an important cause for the experienced disability of patients, respiratory symptoms, and decreases in lungfunction, which require antibiotic therapy at home or in the hospital. Therefore, prevention of exacerbations in CF is important. The aim of this study was to assess the predictive properties of inflammatory markers in exhaled breath for pulmonary exacerbations in children with CF. In addition the reliability of home monitor assessments of symptoms and lungfunction was investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Cystic Fibrosis, care as usual | – | –Treatment according to the Dutch Central Guidance Committee (CBO) guidelines for CF. Assessments: home monitoring, symptoms, lung function, quality of life and diagnostic assessments of non-invasive inflammatory markers in exhaled air and exhaled breath condensate. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Cystic Fibrosis
Key inclusion criteria (4 listed)
- CF disease is defined as the combination of:
Key exclusion criteria (7 listed)
- cardiac abnormalities;
- mental retardation;
- no technical satisfactory performance of measurements;
- on the waiting list for lung transplantation;
- non-compliance with the home-assessments;
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
Number of exacerbations
Time frame: 1 year
Definition of an exacerbation according to Treggiari MM et al.
1 secondary outcome
Quality of life
Time frame: 1 year
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 17 Jul 2015.
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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.
E Dompeling, PhD MD principal investigator
Maastricht University Medical Centre
3 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 and Children, run by Maastricht University Medical Center at 3 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 7 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 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does the primary outcome measure?
Number of exacerbations (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 17 Jul 2015.