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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01698983

Enrollment

Registered

2012-10-03

Start date

2011-06-30

Completion date

2012-10-31

Last updated

2012-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results