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NCT01084811 Clinical Trial

Chronic Rhinosinusitis: Biochemical Markers and Biofilm

Chronic Rhinosinusitis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01084811
Other study ID # 2009/1720(REK)
Secondary ID
Status Recruiting
Phase N/A
First received March 10, 2010
Last updated July 6, 2011
Start date April 2010
Est. completion date December 2012

Study information
Verified date July 2010
Source University Hospital, Akershus
Contact Kjell-Arild Danielsen, MD
Phone 93402150
Email Kjell.Arild.Danielsen@ahus.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
Study type Observational

Clinical Trial Summary

The investigators will conduct a descriptive, prospective, three-armed study concerning the pathophysiology of chronic rhinosinusitis.

In one part of the study the investigators want to investigate the presence of biofilm in patients with chronic rhinosinusitis both with and without nasal polyps compared with a control group of subjects without chronic rhinosinusitis. The investigators will also compare quality of life in the three groups and correlate disease severity in biofilm patients versus patients where biofilm was not present.

The hypothesis here is that biofilm patients suffers a more severe disease.

In the other arm of the study the investigators will compare the presence of different biochemical compounds in the three study groups. The investigators specifically want to investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The investigators may also add other compounds to our test-battery if interesting candidates surface in the literature during the inclusion period.

The purpose of this part of the study is to investigate candidates for the development of nasal polyposis.

The investigators plan to include 100 patients suffering from chronic rhinosinusitis with nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30 control subjects.

Recruitment information / eligibility
Status Recruiting
Enrollment 230
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of chronic rhinosinusitis based on EPOS3

- Submitted to surgery

- Using nasal corticosteroids

Exclusion Criteria:

- Age below 18 years

- Using antibiotics at the time of surgery

- Using systemic corticosteroids

- Sempers triad

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• biopsy
One or more biopsies from nasal mucosa will be harvested during surgery

Locations
Country Name City State
Norway Ahus Lørenskog Akershus

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

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