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Early detection of exacerbations in mucociliary clearance diseases.


- candidate number13329
- NTR NumberNTR3616
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2012
- Secondary IDs 
- Public TitleEarly detection of exacerbations in mucociliary clearance diseases.
- Scientific TitleEarly detection of pulmonary exacerbations in mucociliary clearance diseases: Molecular fingerprinting by exhaled breath and microbiome analysis.
- ACRONYM
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Primary ciliary dyskinesia
- Inclusion criteria1. CF diagnosis is based on: clinical symptoms in combination with an abnormal sweat test (chloride > 60 mmol/l) and/or identification of mutations in both alleles of the CFTR gene;
2. PCD diagnosis is based on: A combination of clinical symptoms, abnormal movement of cilia on microscopic evaluation of respiratory epithelial biopsies and epithelial cell cultures, or identification of an ultra structural defect in the cilia by electron microscopy;
3. ≥ 6 years of age;
4. Stable respiratory disease for at least 6 weeks ( as determined by the treating physician);
5. Ability to perform lung function measurement.
- Exclusion criteria1. Mental retardation;
2. Diabetes Mellitus (CF complication);
3. Technical unsatisfactory performance of measurements;
4. On the waiting list for lung transplantation;
5. Participation in the PREVEC or VERTEX study (AMC).
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-nov-2012
- planned closingdate1-nov-2013
- Target number of participants100
- InterventionsLongitudinal observational study during one year with collection of 5 exhaled breath and microbiology samples.
- Primary outcome1. Relative changes in electronic nose sensors;
2. Retention time;
3. Abundance and mass to charge ratio from GC-MS analysis.
- Secondary outcome(Change in) bacterial and viral diversity.
- Timepoints3 monthly collection of study samples and during an exacerbation.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. T. Paff
- CONTACT for SCIENTIFIC QUERIESDr. Niki Fens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Respiratory Medicine
- Funding
(Source(s) of Monetary or Material Support)
Merieux Institute
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD18-sep-2012 - 27-sep-2012


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