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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01698983
• Other study ID #: 2011H0055
• Status: Terminated
• Phase: N/A
• First received: October 1, 2012
• Last updated: October 30, 2012
• Start date: June 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Martha Morehouse Medical Pavillion	Columbus	Ohio
United States	Martha Morehouse Medical Pavillion	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jeanette Marketon, MD

Country where clinical trial is conducted

United States,