Chronic Rhinosinusitis: Biochemical Markers and Biofilm

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University Hospital, Akershus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01084811
First received: March 10, 2010
Last updated: July 6, 2011
Last verified: July 2010
  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

Further study details as provided by University Hospital, Akershus:

Biospecimen Retention:   Samples With DNA

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
Study Population

Patients referred to sinonasal surgery at Ahus, Norway

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084811

Contacts
Contact: Kjell-Arild Danielsen, MD 93402150 ext +47 Kjell.Arild.Danielsen@ahus.no

Locations
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         
Sponsors and Collaborators
University Hospital, Akershus
  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 September 15, 2014