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Effect of Prednisone onTregs and TH17

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01002313
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Tracking Information
First Submitted Date October 26, 2009
First Posted Date October 27, 2009
Last Update Posted Date March 27, 2014
Study Start Date November 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 26, 2009)
Treg cell numbers [ Time Frame: pre treatment vs post treatment ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 26, 2009)
Cytokine levels in cultured PBMCs [ Time Frame: pre vs post treatment ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect of Prednisone onTregs and TH17
Official Title Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
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 Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with seasonal allergies taking prednisone and normal controls form the community.
Condition Chronic Rhinosinusitis
Intervention Not Provided
Study Groups/Cohorts
  • normal control
  • Patient treatment group
    Treatment with prednisone
Publications * Watanabe S, Pinto JM, Bashir ME, De Tineo M, Suzaki H, Baroody FM, Naclerio RM, Sharma S. Effect of prednisone on nasal symptoms and peripheral blood T-cell function in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2014 Aug;4(8):609-16. doi: 10.1002/alr.21336. Epub 2014 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 26, 2009)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01002313
Other Study ID Numbers 09-254-A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Chicago
Study Sponsor University of Chicago
Collaborators Not Provided
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago
PRS Account University of Chicago
Verification Date March 2014