Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics

Jeanette Marketon, MD

Status: Terminated

Conditions: Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT01698983

2011H0055

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.