Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Glucocorticosteroid Action in Inflammatory Disease|
- Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes [ Time Frame: Prior to surgery and steroid treatment and day of surgery w/ or w/o having been treated w/ steroids ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Prednisone 30mg once daily x 5 days
No Intervention: No Intervention
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.
- 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.
- Steroid induced changes in inflammation will differ in chronic sinus patients with polyps than in those without polyps.
- Changes in inflammation will correlate with clinical variables.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841802
|Contact: Robert P Schleimer, Ph.D.||firstname.lastname@example.org|
|Contact: Kathleen E. Harris, B.S.||email@example.com|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Sub-Investigator: Robert C Kern, MD|
|Sub-Investigator: David B Conley, MD|
|Sub-Investigator: Anju Tripathi-Peters, MD|
|Sub-Investigator: Leslie Grammer, MD|
|Principal Investigator: Robert P Schleimer, PhD|
|Principal Investigator:||Robert P Schleimer, PhD||Northwestern University and Northwestern Memorial Hospital|