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

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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

Study Description
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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.


Condition or disease
Chronic Rhinosinusitis

Study Design
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Study Type : Observational
Actual Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic Rhinosinusitis in a Danish Population: Evaluation of Causes of Disease, Progress and Treatment
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011
Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
Blodsamples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • residents on Funen aged 18-75 years

Exclusion Criteria:

Contacts and Locations
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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): NCT01402349


Sponsors and Collaborators
Odense University Hospital
Investigators
Principal Investigator: Bibi Lange, MD Department of Otorhinolaryngology, Odense University Hospital
More Information
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Responsible Party: Bibi Lange, Department of otorhinolaryngology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01402349     History of Changes
Other Study ID Numbers: Rhino-2010
First Posted: July 26, 2011    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: July 2011

Keywords provided by Odense University Hospital:
Chronic rhinosinusitis, SNOT 22, Quality of life

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases