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Effect of Prednisone onTregs and TH17

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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

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.

Condition or disease
Chronic Rhinosinusitis

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Group/Cohort
normal control
Patient treatment group
Treatment with prednisone



Primary Outcome Measures :
  1. Treg cell numbers [ Time Frame: pre treatment vs post treatment ]

Secondary Outcome Measures :
  1. Cytokine levels in cultured PBMCs [ Time Frame: pre vs post treatment ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with seasonal allergies taking prednisone and normal controls form the community.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01002313


Locations
United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Robert M Naclerio, MD University of Chicago

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01002313     History of Changes
Other Study ID Numbers: 09-254-A
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents