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OpenTrials
Completed

NCT Number: NCT01002313

Effect of Prednisone onTregs and TH17

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Chicago

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Treg cell numbers

    Time frame: pre treatment vs post treatment

Secondary outcomes

  1. Cytokine levels in cultured PBMCs

    Time frame: pre vs post treatment

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Mar 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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