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Neusbijholteontstekingen en neuspoliepen bij volwassenen met taaislijmziekte.


- candidate number10395
- NTR NumberNTR3088
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2011
- Secondary IDs11-010 METC
- Public TitleNeusbijholteontstekingen en neuspoliepen bij volwassenen met taaislijmziekte.
- Scientific TitleRhinosinusitis and nasal polyps in adults with Cystic Fibrosis.
- ACRONYMSinonasal pathology and CF
- hypothesisPrevalence of rhinosinusitis and nasal polyps in CF patients is higher.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Rhinosinusitis, Nasal polyps
- Inclusion criteria1. Confirmed diagnose of Cystic Fibrosis based on genotyping or a positive sweat test;
2. Age equal to or above 18 years.
- Exclusion criteria1. Gross immunodeficiency (congenital of acquired);
2. Congenital mucociliary problems other than CF (e.g. Primairy ciliary dyskinesia);
3. ASA syndrome (Samter's triad; nasal polyps, asthma and aspirin sensitivity);
4. Cocaine abuse;
5. Intranasal neoplasia;
6. Systemic vasculitis and granulomatous diseases (e.g. M.Wegener, sarcoidosis, Churg-Strauss syndrome);
7. Allergy or intolerance to xylometazoline and lidocaine;
8. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 8-apr-2011
- planned closingdate8-apr-2012
- Target number of participants100
- InterventionsN/A
- Primary outcomePrevalence of rhinosinusitis and/or nasal polyps.
- Secondary outcome1. Disease specific quality of life (score on Rhinosinusitis Outcome Measure-31);
2. Outcome of ENT examination (on a standardized form);
3. Upper airway cultures (nasal lavage and middle meatal swabs);
4. Sputum cultures;
5. Nasal airway resistance;
6. Computed tomography of sinuses and volume estimation of sinuses.
- TimepointsOne visit for each subject.
Prevalence of rhinosinusitis and/or nasal polyps can be estimated after 100 patients, approximately after one year.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. Maaike Berkhout
- CONTACT for SCIENTIFIC QUERIESDrs. Maaike Berkhout
- Sponsor/Initiator Haga Teaching Hospital, Department of Pulmonology
- Funding
(Source(s) of Monetary or Material Support)
Haga Teaching Hospital, Department of Pulmonology
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD29-sep-2011 - 18-okt-2011


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