Prevalence of Chronic Rhinosinusitis in Cystic Fibrosis

December 3, 2014 updated by: PD Dr. Jochen G. Mainz, University of Jena
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

187

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Thüringen
      • Jena, Thüringen, Germany, 07740
        • Friedrich-Schiller-Universität

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject has a confirmed diagnosis of cystic fibrosis

Exclusion Criteria:

  • current systemic therapy against Pseudomonas aeruginosa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • nasal lavage and induced sputum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathogen colonization in upper and lower airways
Time Frame: 3yrs
3yrs
Sinonasal symptoms (SNOT-20)
Time Frame: 3 yrs
3 yrs
rhinomanometry and rhinoscopy
Time Frame: 3yrs
3yrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jena

Investigators

  • Study Chair: Jochen G. Mainz, M.D., University of Jena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 15, 2005

First Submitted That Met QC Criteria

December 15, 2005

First Posted (Estimate)

December 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF_Sinusitis_QS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sinusitis

Clinical Trials on Assessment of upper and lower airway colonization, sinonasal symptoms, history, rhinoscopy and rhinomanometry.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe