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. Identifier: NCT00841802
Recruitment Status : Active, not recruiting
First Posted : February 11, 2009
Last Update Posted : December 7, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Schleimer, Northwestern University

February 9, 2009
February 11, 2009
December 7, 2017
July 2008
December 31, 2018   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00841802 on Archive Site
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Not Provided
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Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
Glucocorticosteroid Action in Inflammatory Disease
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.

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.


  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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Chronic Sinusitis
  • Rhinosinusitis
  • Nasal Polyps
Drug: Prednisone
Prednisone 30mg once daily x 5 days
Other Names:
  • Glucocorticoid
  • Deltasone
  • Liquid Pred
  • Meticorten
  • Orasone
  • Prednicen-M
  • Prednicot
  • Sterapred
  • Experimental: Prednisone
    Steroid medication
    Intervention: Drug: Prednisone
  • No Intervention: No Intervention
    No Intervention

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
June 30, 2019
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 18 years to 70 years
  • Diagnosis of chronic rhinosinusitis (CRS) with nasal polyps (NP) and will be undergoing sinonasal surgery for this condition
  • Diagnosis of CRS without NP and will be undergoing sinonasal surgery for this condition
  • No diagnosis of CRS and NP and will be undergoing nasal surgery (septoplasty/rhinoplasty, nasal fracture repair,etc.)

Exclusion Criteria:

  • Ages younger than 18 years and ages older than 70 years
  • Diagnosis of an established immunodeficiency, pregnancy, coagulation disorder, a diagnosis of allergic fungal sinusitis (AFS), or cystic fibrosis
  • Those with CRS with or without NP in whom systemic steroid therapy would be contraindicated
  • Those who are dependent on systemic steroid therapy for sinonasal disease or any other condition
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
5R37HL068546 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Robert Schleimer, Northwestern University
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Robert P Schleimer, PhD Northwestern University and Northwestern Memorial Hospital
Northwestern University
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP