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Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266474
First Posted: December 16, 2005
Last Update Posted: December 4, 2014
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. 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 and the colonisation with Pseudomonas aerug. in the upper airways in patients with cystic fibrosis.

Condition Intervention
Cystic Fibrosis Sinusitis Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Chronic Rhinosinusitis 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:
  • Pathogen colonization in upper and lower airways [ Time Frame: 3yrs ]
  • Sinonasal symptoms (SNOT-20) [ Time Frame: 3 yrs ]
  • rhinomanometry and rhinoscopy [ Time Frame: 3yrs ]

Biospecimen Retention:   Samples With DNA
Pseudomonas aeruginosa and Staphylococcus aureus cultures (SNPS)

Enrollment: 187
Study Start Date: December 2005
Study Completion Date: September 2007
Groups/Cohorts Assigned Interventions
Cross sectional CF study
Multicentric study, including 187 CF patients of all age groupr in 5 CF centres.
Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.
Other Name: nasal lavage and induced sputum

  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
Criteria

Inclusion Criteria:

  • Subject has a confirmed diagnosis of cystic fibrosis

Exclusion Criteria:

  • current systemic therapy against Pseudomonas aeruginosa
  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): NCT00266474


Locations
Germany
Friedrich-Schiller-Universität
Jena, Thüringen, Germany, 07740
Sponsors and Collaborators
University of Jena
Investigators
Study Chair: Jochen G. Mainz, M.D. University of Jena
  More Information

Publications:
Responsible Party: PD Dr. Jochen G. Mainz, Head of CF Center, Pediatric Pulmonology, University of Jena
ClinicalTrials.gov Identifier: NCT00266474     History of Changes
Other Study ID Numbers: CF_Sinusitis_QS
First Submitted: December 15, 2005
First Posted: December 16, 2005
Last Update Posted: December 4, 2014
Last Verified: December 2014

Keywords provided by PD Dr. Jochen G. Mainz, University of Jena:
Cystic Fibrosis with Chronic Rhinosinusitis

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