DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Chronic Rhinosinusitis w/o Nasal Polyps

Study type: Observational

Funder types: Other

Identifiers

NCT01001819

05-01-005E

Details and patient eligibility

About

Analysis of differential gene expression in patients with chronic rhinosinusitis without polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical outcomes.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Affected patients:

• Two or more of the following symptoms should be present for 12 weeks or more: anterior mucopurulent drainage, posterior mucopurulent drainage; nasal obstruction; and facial pain-pressure-fullness.

  • Signs of nasal inflammation such as discolored mucus, edema of the middle meatus or ethmoid area should be documented by endoscopy.
  • The symptoms of rhinosinusitis have failed to resolve or have recurred after a treatment course with antibiotics and nasal and/or oral steroids.
  • The diagnosis of rhinosinusitis should be confirmed with a CT scan.
  • Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium
  • Patients were not previously diagnosed with reactive airway disease or aspirin sensitivity.
  • Patients also must meet the standard criteria for endoscopic sinus surgery and scheduled to undergo their procedure at MMC.

Unaffected Patients:

Patients undergoing elective nasal surgery at MMC.

• Patients deny symptoms of allergic rhinitis such as nasal congestion, nasal discharge, itching, sneezing.

• Patients deny symptoms of chronic or acute rhinosinusitis such as nasal obstruction, facial pain-fullness-pressure, anosmia, anterior and/or posterior mucopurulent drainage.

• Nasal endoscopy showed no evidence of nasal inflammatory disease, such as erythema, edema, polyps, or discolored mucus.

• Patients do not have history of prior sinus surgeries and were not previously diagnosed with CRS.

  1. Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium.
  2. Patients were not diagnosed with reactive airway disease or aspirin sensitivity.

• The absence of evidence of inflammation, such as inflammatory infiltrate or epithelial dysplasia on histopathologic exam of nasal mucosa obtained during surgical procedure.

Trial design

30 participants in 2 patient groups

1

Description:

Chronic Rhinosinusitis w/o nasal polyps

2

Description:

No sinus disease