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

This study is currently recruiting participants.
Verified October 2016 by PD Dr. Jochen G. Mainz, University of Jena
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803881
First Posted: December 8, 2008
Last Update Posted: October 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena
  Purpose
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 With Other Manifestations Sinusitis 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 PD Dr. Jochen G. Mainz, University of Jena:

Primary Outcome Measures:
  • Dynamics in CF upper and lower airway colonization with pathogens [ Time Frame: 10 years ]
    longitudinal non-invasive sampling of upper and lower airways in CF

  • Assessment of ability to smell in CF patients [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • pulmonary function / BMI [ Time Frame: 10 years ]

Estimated Enrollment: 180
Study Start Date: December 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (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
Other Name: Pseudomonas aeruginosa antibodies in serum

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients of the CF outpatients clinic and hospitalized CF patients
Criteria

Inclusion Criteria:

  • Subject has a confirmed diagnosis of cystic fibrosis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803881


Contacts
Contact: Jochen Mainz, MD +49 3641 938425 Jochen.Mainz@med.uni-jena.de

Locations
Germany
University of Jena - CF-Center Recruiting
Jena, Germany, 07740
Contact: Jochen Mainz, MD    +49 3641 938425    Jochen.Mainz@med.uni-jena.de   
Sponsors and Collaborators
University of Jena
Investigators
Study Chair: Jochen Mainz, MD University of Jena - CF Center
  More Information

Publications:
Responsible Party: PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of Jena
ClinicalTrials.gov Identifier: NCT00803881     History of Changes
Other Study ID Numbers: CF_Sinusitis_LS
First Submitted: December 5, 2008
First Posted: December 8, 2008
Last Update Posted: October 25, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Sinusitis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases