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Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00266474
Recruitment Status : Completed
First Posted : December 16, 2005
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
PD Dr. Jochen G. Mainz, University of Jena

Brief Summary:
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 or disease Intervention/treatment
Cystic Fibrosis Sinusitis Other: Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.

Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis
Study Start Date : December 2005
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Pathogen colonization in upper and lower airways [ Time Frame: 3yrs ]
  2. Sinonasal symptoms (SNOT-20) [ Time Frame: 3 yrs ]
  3. rhinomanometry and rhinoscopy [ Time Frame: 3yrs ]

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


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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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

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 Posted: December 16, 2005    Key Record Dates
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