Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

Tracking Information
First Submitted Date ICMJE	February 9, 2009
First Posted Date ICMJE	February 11, 2009
Last Update Posted Date	December 7, 2017
Study Start Date ICMJE	July 2008
Estimated Primary Completion Date	December 31, 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 10, 2009)	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: None (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
Study Arms	Experimental: Prednisone Steroid medication Intervention: Drug: Prednisone; No Intervention: No Intervention No Intervention
Publications *	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.; 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.; 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.; 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.; 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.; 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.; 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.; 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.; 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. Epub 2007 Oct 18. Review.; 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. Epub 2007 Oct 24. Review.; 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.; Schleimer RP, Lane AP, Kim J. Innate and acquired immunity and epithelial cell function in chronic rhinosinusitis. Clin Allergy Immunol. 2007;20:51-78. Review.; 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.; 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.; 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.; Anand VK, Kacker A, Orjuela AF, Huang C, Manarey C, Xiang J. Inflammatory pathway gene expression in chronic rhinosinusitis. Am J Rhinol. 2006 Jul-Aug;20(4):471-6.; Schleimer RP. Glucocorticoids suppress inflammation but spare innate immune responses in airway epithelium. Proc Am Thorac Soc. 2004;1(3):222-30. Review.; 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.; 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.
* 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
Actual Enrollment ICMJE; (submitted: February 10, 2009)	50
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	June 30, 2019
Estimated Primary Completion Date	December 31, 2018 (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 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP