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NCT00266474 Clinical Trial

Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:
Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00266474
Other study ID # CF_Sinusitis_QS
Secondary ID
Status Completed
Phase N/A
First received December 15, 2005
Last updated December 3, 2014
Start date December 2005
Est. completion date September 2007

Study information
Verified date December 2014
Source University of Jena
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

Aim of the study is to detect the prevalence of chronic rhinosinusitis and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.

Recruitment information / eligibility
Status Completed
Enrollment 187
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Subject has a confirmed diagnosis of cystic fibrosis

Exclusion Criteria:

- current systemic therapy against Pseudomonas aeruginosa

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.

Locations
Country Name City State
Germany Friedrich-Schiller-Universität Jena Thüringen

Sponsors (1)
Lead Sponsor Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Mainz JG, Naehrlich L, Schien M, Käding M, Schiller I, Mayr S, Schneider G, Wiedemann B, Wiehlmann L, Cramer N, Pfister W, Kahl BC, Beck JF, Tümmler B. Concordant genotype of upper and lower airways P aeruginosa and S aureus isolates in cystic fibrosis. Thorax. 2009 Jun;64(6):535-40. doi: 10.1136/thx.2008.104711. Epub 2009 Mar 11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pathogen colonization in upper and lower airways 3yrs No
Primary Sinonasal symptoms (SNOT-20) 3 yrs No
Primary rhinomanometry and rhinoscopy 3yrs Yes
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