Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena
ClinicalTrials.gov Identifier:
NCT00266474
First received: December 15, 2005
Last updated: December 3, 2014
Last verified: December 2014
  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 University of Jena:

Primary Outcome Measures:
  • Pathogen colonization in upper and lower airways [ Time Frame: 3yrs ] [ Designated as safety issue: No ]
  • Sinonasal symptoms (SNOT-20) [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • rhinomanometry and rhinoscopy [ Time Frame: 3yrs ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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
Study First Received: December 15, 2005
Last Updated: December 3, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
Cystic Fibrosis with Chronic Rhinosinusitis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2015