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Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment

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.
 
ClinicalTrials.gov Identifier: NCT01402349
Recruitment Status : Completed
First Posted : July 26, 2011
Last Update Posted : August 2, 2011
Sponsor:
Information provided by:
Odense University Hospital

Tracking Information
First Submitted Date July 25, 2011
First Posted Date July 26, 2011
Last Update Posted Date August 2, 2011
Study Start Date April 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment
Official Title Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment
Brief Summary

Introduction: Chronic Rhinosinusitis (CRS) is defined as inflammation of the nose and the paranasal sinuses. It is a very common disorder increasing in both incidence and prevalence with significant impact on quality of life and substantial health care costs. In this study we evaluate the prevalence of CRS in Denmark and there is a need for consensus about diagnosing this disease. Different questionnaires and different tests used for examination are evaluated together with the patients compliance and days lost through illness.

Methods: As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires self reported CRS was evaluated. Respondents were invited for clinical examination including spirometry, skin prick test, bloodsample and an ENT examination including nasal endoscopy, acoustic rhinometry, peak nasal inspiratory flow and smell test. Questionnaire on quality of life (EQ-5D) and symptom severity (SNOT-22) was completed. Medical diagnosed CRS was diagnosed according to the definition on CRS stated by EPOS (European Position Paper on Rhinosinusitis and Nasal Polyps 2007). CRS is defined as inflammation in the nose and paranasal sinus and should be characterized by two or more symptoms one of which should be either nasal blockage/obstruction/congestion or nasal discharge, +/- facial pain/pressure, +/- reduction or loss of smell. Endoscopic signs should be present and symptoms must have been present > 12 weeks. Patients diagnosed with CRS were invited for a 1 year and 2 year follow up where examination and questionnaires were repeated and treatment compliance and days lost through illness were evaluated.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blodsamples.
Sampling Method Non-Probability Sample
Study Population As part of Ga2len (Global Asthma and Allergy European Network) a questionnaire on CRS was posted to 5000 residents on Funen. From the completed and returned questionnaires self reported CRS was evaluated. Respondents were invited for clinical examination. Patients diagnosed with CRS were invited for a 1 year and 2 year follow up.
Condition Chronic Rhinosinusitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July¬†25,¬†2011)
5000
Original Actual Enrollment Same as current
Actual Study Completion Date April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • residents on Funen aged 18-75 years

Exclusion Criteria:

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01402349
Other Study ID Numbers Rhino-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bibi Lange, Department of otorhinolaryngology, Odense University Hospital
Study Sponsor Odense University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Bibi Lange, MD Department of Otorhinolaryngology, Odense University Hospital
PRS Account Odense University Hospital
Verification Date July 2011