Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT00841802
Status:
WITHDRAWN
Last Update Posted:
2020-04-02
First Post:
2009-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
Glucocorticosteroid Action in Inflammatory Disease
Status:
WITHDRAWN
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Realized there was a design flaw.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study to evaluate the cause of chronic sinus disease. Oral steroids have long been used in the treatment of inflammatory conditions including chronic sinusitis, asthma, and arthritis. However, it is not well known exactly which patients will benefit from steroids when used in the treatment of chronic sinusitis. For some doctors, it is common practice to use these medications prior to planned sinus surgery, to lessen the inflammation and possibly help the healing process. Other doctors feel oral steroids may not be helpful in this way, and there is no conclusive data as to whether this practice has a long term benefit.
Detailed Description:
The purpose of this research study is to better understand how this potential treatment option, oral steroids, affects biochemical substances that have been associated with the development of chronic sinusitis and polyps. In order to do this, we need to study people with different forms of chronic sinusitis and compare them to individuals without allergies or sinus disease. We will also look at patients with chronic sinusitis who are treated with oral steroids and compare them to chronic sinus patients who have not received oral steroid therapy prior to surgery. This study may help pave the way to new treatments that address specific parts of the chronic sinus inflammatory pathway.
Hypotheses
1. Oral steroid treatment of patients with CRS will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage.
2. Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
3. Changes in inflammation will correlate with clinical variables.
Hypotheses
1. Oral steroid treatment of patients with CRS will lead to a correction in the inflammation that is observed in sinonasal tissues, nasal brushings, and nasal lavage.
2. Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
3. Changes in inflammation will correlate with clinical variables.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R37HL068546 | NIH | None | https://reporter.nih.gov/quic… | View |