Chronic Rhinosinusitis: Biochemical Markers and Biofilm
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Rhinosinusitis |
Procedure: biopsy |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
Nasal mucosa and nasal polyps
| Estimated Enrollment: | 230 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| chronic rhinosinusitis with nasal polyps |
Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
|
| chronic rhinosinusitis without nasal polyps |
Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
|
| Control group |
Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients referred to sinonasal surgery at Ahus, Norway
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
Contacts and Locations| Contact: Kjell-Arild Danielsen, MD | 93402150 ext +47 | Kjell.Arild.Danielsen@ahus.no |
| Norway | |
| Ahus | Recruiting |
| Lørenskog, Akershus, Norway, 1478 | |
| Contact: Erik S Lie, MD 90687197 ext +47 Erik.S.Lie@ahus.no | |
| Principal Investigator: Kjell-Arild Danielsen, MD | |
More Information
No publications provided
| Responsible Party: | Erik S Lie, University Hospital, Akershus |
| ClinicalTrials.gov Identifier: | NCT01084811 History of Changes |
| Other Study ID Numbers: | 2009/1720(REK) |
| Study First Received: | March 10, 2010 |
| Last Updated: | July 6, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services Norway: Directorate of Health |
Additional relevant MeSH terms:
|
Sinusitis Paranasal Sinus Diseases Nose Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013