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Chronic Sinusitis | Chronic Rhinosinusitis With or Without Nasal Polyps Steroid Study

Chronic Sinusitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Sinusitis

Rhinosinusitis

Nasal Polyps

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:PrednisonePrednisone 30mg once daily x 5 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PrednisoneSteroid medication

No InterventionNo Intervention

Study Status

Active, not recruiting

Start Date: July 2008

Completed Date: December 31, 2019

Phase: Phase 4

Type: Interventional

Design:

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

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Robert P Schleimer, PhD

Lead Sponsor: Northwestern University

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT00841802

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.

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