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Chronic Rhinosinusitis: Biochemical Markers and Biofilm

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01084811
Enrollment
230
Registered
2010-03-11
Start date
2010-04-30
Completion date
2012-12-31
Last updated
2011-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis

Brief 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.

Interventions

PROCEDUREbiopsy

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

Sponsors

University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

Norway

Contacts

Primary ContactKjell-Arild Danielsen, MD
Kjell.Arild.Danielsen@ahus.no93402150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026