Effect of Prednisone onTregs and TH17

Chronic Rhinosinusitis Clinical Trial

Official title:

Effect of Prednisone on Peripheral Blood T-cell Function (Tregs and Th17) in Patients With Chronic Rhinosinusitis (CRS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002313
• Other study ID #: 09-254-A
• Status: Completed
• Phase: Phase 1
• First received: October 26, 2009
• Last updated: March 26, 2014
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: March 2014
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Rhinosinusitis

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treg cell numbers		pre treatment vs post treatment	No
Secondary	Cytokine levels in cultured PBMCs		pre vs post treatment	No