Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Jena
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena Identifier:
First received: December 5, 2008
Last updated: December 3, 2014
Last verified: December 2014

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.

Condition Intervention
Cystic Fibrosis
Other: nasal lavage and sputum collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Chronic Rhinosinusitis, Pathogen-colonization in the Upper and Lower Airways and Ability to Smell in Cystic Fibrosis

Resource links provided by NLM:

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • Dynamics in CF upper and lower airway colonization with pathogens [ Time Frame: 10 years ] [ Designated as safety issue: No ]
    longitudinal non-invasive sampling of upper and lower airways in CF

  • Assessment of ability to smell in CF patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pulmonary function / BMI [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: December 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CF patients of all age groups
Longitudinal prospective assessment of upper and lower airway colonization in all patients attended in the Jena University CF centre
Other: nasal lavage and sputum collection
non-invasive longitudinal assessment of pathogen colonization in both airway levels

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients of the CF outpatients clinic and hospitalized CF patients


Inclusion Criteria:

  • Subject has a confirmed diagnosis of cystic fibrosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00803881

Contact: Jochen Mainz, MD +49 3641 938425

University of Jena - CF-Center Recruiting
Jena, Germany, 07740
Contact: Jochen Mainz, MD    +49 3641 938425   
Sponsors and Collaborators
University of Jena
Study Chair: Jochen Mainz, MD University of Jena - CF Center
  More Information

Responsible Party: PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of Jena Identifier: NCT00803881     History of Changes
Other Study ID Numbers: CF_Sinusitis_LS
Study First Received: December 5, 2008
Last Updated: December 3, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Cystic Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases processed this record on March 03, 2015