Research with human participants

Overview of medical research in the Netherlands

Neusbijholteontstekingen en neuspoliepen bij volwassenen met taaislijmziekte.

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Ethical review
Positive opinion
Status
Recruiting
Health condition type
-
Study type
Observational non invasive

ID

NL-OMON28476

Source

NTR

Brief title

Sinonasal pathology and CF

Health condition

Cystic Fibrosis, nasal polyps, rhinosinusitis,
Taaislijmziekte, neuspoliepen, rhinosinusitis

Sponsors and support

Primary sponsor :
H.G.M. Heijerman, MD PhD & M.C. Berkhout, MD
Pulmonary Department
Haga Teaching Hospital, The Hague
Source(s) of monetary or material Support :
Study related intervention are covered by standard care.
Personel costs are met from a private researchfund.

Intervention

Outcome measures

Primary outcome

Prevalence of rhinosinusitis and/or nasal polyps.

Secondary outcome

1. 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.

Background summary

N/A

Study objective

Prevalence of rhinosinusitis and nasal polyps in CF patients is higher.

Study design

One visit for each subject.

Prevalence of rhinosinusitis and/or nasal polyps can be estimated after 100 patients, approximately after one year.

Intervention

N/A

Public
Leyweg 275
Maaike Berkhout
Den Haag 2504 LN
The Netherlands
+31 (0)70 2102076
M.Berkhout@hagaziekenhuis.nl
Scientific
Leyweg 275
Maaike Berkhout
Den Haag 2504 LN
The Netherlands
+31 (0)70 2102076
M.Berkhout@hagaziekenhuis.nl

Inclusion criteria

1. Confirmed diagnose of Cystic Fibrosis based on genotyping or a positive sweat test;

2. Age equal to or above 18 years.

Exclusion criteria

1. 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.

Design

Study type :
Observational non invasive
Intervention model
:
Parallel
Allocation :
Non controlled trial
Masking :
Open (masking not used)
Control :
N/A , unknown

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
100
Type :
Anticipated

Positive opinion
Date :
Application type :
First submission

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
NTR-new NL2941
NTR-old NTR3088
Other METC : 11-010
ISRCTN ISRCTN wordt niet meer aangevraagd.

Summary results

N/A