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Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

Primary Purpose

Chronic Sinusitis, Rhinosinusitis, Nasal Polyps

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring Chronic sinusitis, Chronic rhinosinusitis, Nasal polyps

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prednisone

No Intervention

Arm Description

Steroid medication

No Intervention

Outcomes

Primary Outcome Measures

Alterations of inflammatory cells, levels of key antibodies and cytokines, and expression of key epithelial genes

Secondary Outcome Measures

Full Information

First Posted
February 9, 2009
Last Updated
March 31, 2020
Sponsor
Northwestern University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00841802
Brief Title
Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study
Official Title
Glucocorticosteroid Action in Inflammatory Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Realized there was a design flaw.
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis, Rhinosinusitis, Nasal Polyps
Keywords
Chronic sinusitis, Chronic rhinosinusitis, Nasal polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Experimental
Arm Description
Steroid medication
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
Glucocorticoid, Deltasone, Liquid Pred, Meticorten, Orasone, Prednicen-M, Prednicot, Sterapred
Intervention Description
Prednisone 30mg once daily x 5 days
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schleimer, PhD
Organizational Affiliation
Northwestern University and Northwestern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17002703
Citation
Van Zele T, Claeys S, Gevaert P, Van Maele G, Holtappels G, Van Cauwenberge P, Bachert C. Differentiation of chronic sinus diseases by measurement of inflammatory mediators. Allergy. 2006 Nov;61(11):1280-9. doi: 10.1111/j.1398-9995.2006.01225.x.
Results Reference
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PubMed Identifier
7921442
Citation
Kanai N, Denburg J, Jordana M, Dolovich J. Nasal polyp inflammation. Effect of topical nasal steroid. Am J Respir Crit Care Med. 1994 Oct;150(4):1094-100. doi: 10.1164/ajrccm.150.4.7921442.
Results Reference
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PubMed Identifier
12150618
Citation
Lavigne F, Cameron L, Renzi PM, Planet JF, Christodoulopoulos P, Lamkioued B, Hamid Q. Intrasinus administration of topical budesonide to allergic patients with chronic rhinosinusitis following surgery. Laryngoscope. 2002 May;112(5):858-64. doi: 10.1097/00005537-200205000-00015.
Results Reference
background
PubMed Identifier
18075447
Citation
Wright ED, Agrawal S. Impact of perioperative systemic steroids on surgical outcomes in patients with chronic rhinosinusitis with polyposis: evaluation with the novel Perioperative Sinus Endoscopy (POSE) scoring system. Laryngoscope. 2007 Nov;117(11 Pt 2 Suppl 115):1-28. doi: 10.1097/MLG.0b013e31814842f8.
Results Reference
background
PubMed Identifier
17084217
Citation
Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, Adinoff AD, Bachert C, Borish L, Chinchilli VM, Danzig MR, Ferguson BJ, Fokkens WJ, Jenkins SG, Lund VJ, Mafee MF, Naclerio RM, Pawankar R, Ponikau JU, Schubert MS, Slavin RG, Stewart MG, Togias A, Wald ER, Winther B; Rhinosinusitis Initiative. Rhinosinusitis: developing guidance for clinical trials. J Allergy Clin Immunol. 2006 Nov;118(5 Suppl):S17-61. doi: 10.1016/j.jaci.2006.09.005.
Results Reference
background
PubMed Identifier
18588753
Citation
Richer SL, Truong-Tran AQ, Conley DB, Carter R, Vermylen D, Grammer LC, Peters AT, Chandra RK, Harris KE, Kern RC, Schleimer RP. Epithelial genes in chronic rhinosinusitis with and without nasal polyps. Am J Rhinol. 2008 May-Jun;22(3):228-34. doi: 10.2500/ajr.2008.22.3162.
Results Reference
background
PubMed Identifier
18410958
Citation
Kato A, Peters A, Suh L, Carter R, Harris KE, Chandra R, Conley D, Grammer LC, Kern R, Schleimer RP. Evidence of a role for B cell-activating factor of the TNF family in the pathogenesis of chronic rhinosinusitis with nasal polyps. J Allergy Clin Immunol. 2008 Jun;121(6):1385-92, 1392.e1-2. doi: 10.1016/j.jaci.2008.03.002. Epub 2008 Apr 14.
Results Reference
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PubMed Identifier
17473687
Citation
Xu G, Mou Z, Jiang H, Cheng L, Shi J, Xu R, Oh Y, Li H. A possible role of CD4+CD25+ T cells as well as transcription factor Foxp3 in the dysregulation of allergic rhinitis. Laryngoscope. 2007 May;117(5):876-80. doi: 10.1097/MLG.0b013e318033f99a.
Results Reference
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PubMed Identifier
17949801
Citation
Schleimer RP, Kato A, Kern R, Kuperman D, Avila PC. Epithelium: at the interface of innate and adaptive immune responses. J Allergy Clin Immunol. 2007 Dec;120(6):1279-84. doi: 10.1016/j.jaci.2007.08.046. Epub 2007 Oct 18.
Results Reference
background
PubMed Identifier
17928212
Citation
Kato A, Schleimer RP. Beyond inflammation: airway epithelial cells are at the interface of innate and adaptive immunity. Curr Opin Immunol. 2007 Dec;19(6):711-20. doi: 10.1016/j.coi.2007.08.004. Epub 2007 Oct 24.
Results Reference
background
PubMed Identifier
17617600
Citation
Kato A, Favoreto S Jr, Avila PC, Schleimer RP. TLR3- and Th2 cytokine-dependent production of thymic stromal lymphopoietin in human airway epithelial cells. J Immunol. 2007 Jul 15;179(2):1080-7. doi: 10.4049/jimmunol.179.2.1080.
Results Reference
background
PubMed Identifier
17534045
Citation
Schleimer RP, Lane AP, Kim J. Innate and acquired immunity and epithelial cell function in chronic rhinosinusitis. Clin Allergy Immunol. 2007;20:51-78.
Results Reference
background
PubMed Identifier
17082634
Citation
Kato A, Truong-Tran AQ, Scott AL, Matsumoto K, Schleimer RP. Airway epithelial cells produce B cell-activating factor of TNF family by an IFN-beta-dependent mechanism. J Immunol. 2006 Nov 15;177(10):7164-72. doi: 10.4049/jimmunol.177.10.7164.
Results Reference
background
PubMed Identifier
17063750
Citation
Conley DB, Tripathi A, Seiberling KA, Schleimer RP, Suh LA, Harris K, Paniagua MC, Grammer LC, Kern RC. Superantigens and chronic rhinosinusitis: skewing of T-cell receptor V beta-distributions in polyp-derived CD4+ and CD8+ T cells. Am J Rhinol. 2006 Sep-Oct;20(5):534-9. doi: 10.2500/ajr.2006.20.2941.
Results Reference
background
PubMed Identifier
16686375
Citation
Lane AP, Truong-Tran QA, Schleimer RP. Altered expression of genes associated with innate immunity and inflammation in recalcitrant rhinosinusitis with polyps. Am J Rhinol. 2006 Mar-Apr;20(2):138-44.
Results Reference
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PubMed Identifier
16955782
Citation
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Results Reference
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PubMed Identifier
16113438
Citation
Schleimer RP. Glucocorticoids suppress inflammation but spare innate immune responses in airway epithelium. Proc Am Thorac Soc. 2004;1(3):222-30. doi: 10.1513/pats.200402-018MS.
Results Reference
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PubMed Identifier
17579079
Citation
Zhang N, Truong-Tran QA, Tancowny B, Harris KE, Schleimer RP. Glucocorticoids enhance or spare innate immunity: effects in airway epithelium are mediated by CCAAT/enhancer binding proteins. J Immunol. 2007 Jul 1;179(1):578-89. doi: 10.4049/jimmunol.179.1.578.
Results Reference
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PubMed Identifier
17599560
Citation
Bolger WE, Joshi AS, Spear S, Nelson M, Govindaraj K. Gene expression analysis in sinonasal polyposis before and after oral corticosteroids: a preliminary investigation. Otolaryngol Head Neck Surg. 2007 Jul;137(1):27-33. doi: 10.1016/j.otohns.2007.01.023.
Results Reference
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Links:
URL
https://www.nm.org/doctors/search-results?terms=schleimer#all-1
Description
Principal Investigator Site

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Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

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