Effect of Prednisone onTregs and TH17

NCT ID: NCT01002313

Last Updated: 2014-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Chronic Rhinosinusitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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normal control

No interventions assigned to this group

Patient treatment group

Treatment with prednisone

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert M Naclerio, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 24753507 (View on PubMed)

Other Identifiers

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09-254-A

Identifier Type: -

Identifier Source: org_study_id

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