Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
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Purpose
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.
| Condition |
|---|
|
Asthma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
clinic
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.
Contacts and Locations| United States, Ohio | |
| Martha Morehouse Medical Pavillion | |
| Columbus, Ohio, United States, 43221 | |
| Martha Morehouse Medical Pavillion | |
| Columbus, Ohio, United States, 432211 | |
| Principal Investigator: | Jeanette Marketon, Ph.D. | Recruit and Consent Patients |
More Information
No publications provided
| Responsible Party: | Jeanette Marketon, MD, Assistant Professor, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01698983 History of Changes |
| Other Study ID Numbers: | 2011H0055 |
| Study First Received: | October 1, 2012 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013