Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00841802|
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Sinusitis Rhinosinusitis Nasal Polyps||Drug: Prednisone||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Glucocorticosteroid Action in Inflammatory Disease|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Prednisone 30mg once daily x 5 days
No Intervention: No Intervention
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841802
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Robert P Schleimer, PhD||Northwestern University and Northwestern Memorial Hospital|