Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Schleimer, Northwestern University
ClinicalTrials.gov Identifier:
NCT00841802
First received: February 9, 2009
Last updated: September 16, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Chronic Sinusitis
Rhinosinusitis
Nasal Polyps
Drug: Prednisone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glucocorticosteroid Action in Inflammatory Disease

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisone
Steroid medication
Drug: Prednisone
Prednisone 30mg once daily x 5 days
Other Names:
  • Glucocorticoid
  • Deltasone
  • Liquid Pred
  • Meticorten
  • Orasone
  • Prednicen-M
  • Prednicot
  • Sterapred
  • Sterapred DS
No Intervention: No Intervention
No Intervention

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841802

Contacts
Contact: Robert P Schleimer, Ph.D. 312-503-0076 rpschleimer@northwestern.edu
Contact: Kathleen E. Harris, B.S. 312-503-8095 k-e-harris@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
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         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Robert P Schleimer, PhD Northwestern University and Northwestern Memorial Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Robert Schleimer, Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT00841802     History of Changes
Other Study ID Numbers: STU00010040, 5R37HL068546
Study First Received: February 9, 2009
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Chronic sinusitis
Chronic rhinosinusitis
Nasal polyps

Additional relevant MeSH terms:
Nose Diseases
Chronic Disease
Nasal Polyps
Polyps
Sinusitis
Disease Attributes
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Respiratory Tract Infections
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014