Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
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ClinicalTrials.gov Identifier: NCT01698983
Recruitment Status :
(data not as expected)
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes 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.
Participation in another interventional research trial
Inability or unwillingness to provide consent
Febrile illness (>38.0˚ C or 100.4˚ F) within 24 hours of visit.