Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
Data Collection
Collected from today forward - ProspectiveBronchial Diseases+6
+ Hypersensitivity
+ Hypersensitivity, Immediate
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: June 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Martha Morehouse Medical Pavillion
Columbus, United StatesOpen Martha Morehouse Medical Pavillion in Google MapsMartha Morehouse Medical Pavillion
Columbus, United States