- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002313
Effect of Prednisone onTregs and TH17
March 26, 2014 updated by: University of Chicago
Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- The University of Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with seasonal allergies taking prednisone and normal controls form the community.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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normal control
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Patient treatment group
Treatment with prednisone
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Treg cell numbers
Time Frame: pre treatment vs post treatment
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pre treatment vs post treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cytokine levels in cultured PBMCs
Time Frame: pre vs post treatment
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pre vs post treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 26, 2009
First Submitted That Met QC Criteria
October 26, 2009
First Posted (Estimate)
October 27, 2009
Study Record Updates
Last Update Posted (Estimate)
March 27, 2014
Last Update Submitted That Met QC Criteria
March 26, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-254-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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