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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01001819
Other study ID # 05-01-005E
Secondary ID
Status Completed
Phase
First received October 26, 2009
Last updated April 3, 2018
Start date March 2005
Est. completion date November 18, 2008

Study information

Verified date April 2018
Source Montefiore Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 18, 2008
Est. primary completion date November 18, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Montefiore Medical Center Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States,