Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
This study has been terminated.
(data not as expected)
Information provided by (Responsible Party):
Jeanette Marketon, MD, The Ohio State University
First received: October 1, 2012
Last updated: October 30, 2012
Last verified: October 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
| Study Start Date:
| Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698983
|Martha Morehouse Medical Pavillion
|Columbus, Ohio, United States, 43221 |
|Martha Morehouse Medical Pavillion
|Columbus, Ohio, United States, 432211 |
Jeanette Marketon, MD
||Jeanette Marketon, Ph.D.
||Recruit and Consent Patients
No publications provided
||Jeanette Marketon, MD, Assistant Professor, The Ohio State University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 1, 2012
||October 30, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 14, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs