EX VIVO STIMULATION OF WHOLE BLOOD AS A MEANS TO DETERMINE GLUCOCORTICOID SENSITIVITY TO MILD-TO-MODERATE AND REFRACTORY ASTHMATICS
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | June 2011 |
| Contact: | Jeanette Marketon, M.D. |
| Email: | jeanette.marketon@osumc.edu |
| Phone: | 614-293-3496 |
Gluococorticoids are commonly prescribed to treat a number of diseases including the
majority of inflammatory diseases. Despite considerable inter-personal variability in
responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the
risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to
determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of
this study is to perform a whole blood ex vivo stimulation assay to interrogate known
glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid
sensitivity and compare the results between severe and non-severe asthmatics.
Inclusion criteria:
To be eligible for the study, subjects must meet all of the following criteria:
- Age ≥ 18 years old
- Physician diagnosis of asthma confirmed through medical record documentation.
- Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine
PC 20 score of 16mg/ml or less.
- Non-smoker for > 6 months before enrollment into the trial
- Less than 5 pack year smoking history defined as the average packs smoked per day
multiplied by the years of active smoking.
- Willing and able to adhere to the study visit schedule and other protocol-specified
procedures.
Exclusion criteria:
Subjects meeting any of the following criteria may not be enrolled in the study:
- Existence of lung disease (other than asthma)
- Recent asthma exacerbation requiring hospital admissions, unexpected healthcare
visits, or prednisone courses in the previous 4 weeks.
- Non-English speaking.
- Participation in another interventional research trial
- Self-reported pregnancy
- Inability or unwillingness to provide consent
- Febrile illness (>38.0˚ C or 100.4˚ F) within 24 hours of visit.
We found this trial at
1
site
Click here to add this to my saved trials
