Effect of Prednisone onTregs and TH17
Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 27, 2014
March 1, 2014
6 months
October 26, 2009
March 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Treg cell numbers
pre treatment vs post treatment
Secondary Outcomes (1)
Cytokine levels in cultured PBMCs
pre vs post treatment
Study Arms (2)
normal control
Patient treatment group
Treatment with prednisone
Eligibility Criteria
Patients with seasonal allergies taking prednisone and normal controls form the community.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Chicago
Chicago, Illinois, 60637, United States
Related Publications (1)
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.
PMID: 24753507DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert M Naclerio, MD
University of Chicago
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2009
First Posted
October 27, 2009
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
December 1, 2010
Last Updated
March 27, 2014
Record last verified: 2014-03