Longitudinal Pathogen-colonization in Cystic Fibrosis Airways and Ability to Smell

• Conditions: Cystic Fibrosis With Other Manifestations; Sinusitis

• Registration Number: NCT00803881
• Lead Sponsor: University of Jena

Brief Summary

Aim of the study is to detect the prevalence of chronic rhinosinusitis, pathogen colonization of the lower and upper airways and, in a sub-cohort the sense of smelling in patients with cystic fibrosis.

Detailed Description

The sub-study on the sense of smelling in CF has been finalized in the meantime. Results were published in 2012:

Smell in cystic fibrosis. Lindig J, Steger C, Beiersdorf N, Michl R, Beck JF, Hummel T, Mainz JG. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):915-21. doi: 10.1007/s00405-012-2124-2. Epub 2012 Aug 14.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-05
• Study First Submitted QC: 2008-12-05
• Study First Posted: 2008-12-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25
• Primary Completion: 2018-07
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Subject has a confirmed diagnosis of cystic fibrosis

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dynamics in CF upper and lower airway colonization with pathogens	10 years	longitudinal non-invasive sampling of upper and lower airways in CF
Assessment of ability to smell in CF patients	3 years

Secondary Outcome Measures

Name	Time	Method
pulmonary function / BMI	10 years

Trial Locations

Locations (1)

University of Jena - CF-Center; 🇩🇪 Jena, Germany