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Effect of Prednisone onTregs and TH17

Completed
Conditions
Chronic Rhinosinusitis
Registration Number
NCT01002313
Lead Sponsor
University of Chicago
Brief Summary

The primary objective of this study is to see whether systemic corticosteroids (such as Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with CRS. Patients are taking prednisone as part of their routine medical care.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • Diagnosis of CRS.
  • A CT scan performed in the last year depicting the severity of the disease or nasal polyps on endoscopy.
  • Symptomatic at the time of entry into the study as determined by scores ≥ 1.4 on the Rhinosinusitis disability index
Exclusion Criteria
  • Women who are pregnant or breastfeeding.
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, diabetes, osteoporosis, cataracts, glaucoma, neurological, oncologic, liver disease or a contraindication to taking prednisone).
  • Use of any other investigational agent in the last 30 days.
  • Use of clinical drugs like antihistamines, leukotriene modifiers, intranasal steroids, systemic corticosteroids in the last 15 days or immunotherapy in the last year.
  • Upper respiratory infection within 14 days of study start
  • Smoking within the last 2 months.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Treg cell numberspre treatment vs post treatment
Secondary Outcome Measures
NameTimeMethod
Cytokine levels in cultured PBMCspre vs post treatment

Trial Locations

Locations (1)

The University of Chicago

🇺🇸

Chicago, Illinois, United States

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