Chronic Rhinosinusitis: Biochemical Markers and Biofilm

NCT ID: NCT01084811

Last Updated: 2011-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic rhinosinusitis with nasal polyps

biopsy

Intervention Type PROCEDURE

One or more biopsies from nasal mucosa will be harvested during surgery

chronic rhinosinusitis without nasal polyps

biopsy

Intervention Type PROCEDURE

One or more biopsies from nasal mucosa will be harvested during surgery

Control group

biopsy

Intervention Type PROCEDURE

One or more biopsies from nasal mucosa will be harvested during surgery

Interventions

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biopsy

One or more biopsies from nasal mucosa will be harvested during surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Akershus

Locations

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Ahus

Lørenskog, Akershus, Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Kjell-Arild Danielsen, MD

Role: CONTACT

93402150 ext. +47

Facility Contacts

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Erik S Lie, MD

Role: primary

90687197 ext. +47

Other Identifiers

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2009/1720(REK)

Identifier Type: -

Identifier Source: org_study_id

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