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

Tracking Information

First Received Date ^ICMJE

February 9, 2009

Last Updated Date

December 7, 2016

Start Date ^ICMJE

July 2008

Estimated Primary Completion Date

June 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841802 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

Official Title ^ICMJE

Glucocorticosteroid Action in Inflammatory Disease

Brief Summary

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.

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

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Sinusitis
Rhinosinusitis
Nasal Polyps

Intervention ^ICMJE

Drug: Prednisone

Prednisone 30mg once daily x 5 days

Other Names:

Glucocorticoid
Deltasone
Liquid Pred
Meticorten
Orasone
Prednicen-M
Prednicot
Sterapred
Sterapred DS

Study Arms

Experimental: Prednisone
Steroid medication

Intervention: Drug: Prednisone
No Intervention: No Intervention
No Intervention

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

June 2018

Estimated Primary Completion Date

June 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00841802

Other Study ID Numbers ^ICMJE

STU00010040
5R37HL068546 ( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Robert Schleimer, Northwestern University

Study Sponsor ^ICMJE

Northwestern University

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^ICMJE

Principal Investigator:

Robert P Schleimer, PhD

Northwestern University and Northwestern Memorial Hospital

PRS Account

Northwestern University

Verification Date

December 2016

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

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