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Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00841802
First Posted: February 11, 2009
Last Update Posted: September 13, 2017
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert Schleimer, Northwestern University
  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: None (Open Label)
Primary Purpose: Treatment
Official Title: Glucocorticosteroid Action in Inflammatory Disease

Resource links provided by NLM:


Further study details as provided by Robert Schleimer, 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 ]

Enrollment: 50
Study Start Date: July 2008
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: December 31, 2018 (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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Heart, Lung, and Blood Institute (NHLBI)
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 ( U.S. NIH Grant/Contract )
First Submitted: February 9, 2009
First Posted: February 11, 2009
Last Update Posted: September 13, 2017
Last Verified: September 2017

Keywords provided by Robert Schleimer, Northwestern University:
Chronic sinusitis
Chronic rhinosinusitis
Nasal polyps

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