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Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Schleimer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00841802
First received: February 9, 2009
Last updated: December 7, 2016
Last verified: December 2016
History of Changes
February 9, 2009
December 7, 2016
July 2008
June 2017   (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 ClinicalTrials.gov Archive Site
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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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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
  • Sterapred DS
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
June 2018
June 2017   (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)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00841802
STU00010040
5R37HL068546 ( US NIH Grant/Contract Award Number )
Yes
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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 2016

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