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

NCT01698983 | Terminated

• 1 other identifier: 2011H0055
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

clinic

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeanette Marketon, MD: lead

Study Sites (2)

Martha Morehouse Medical Pavillion

Columbus, Ohio, 432211, United States

Location

Martha Morehouse Medical Pavillion

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Jeanette Marketon, Ph.D.

  Recruit and Consent Patients

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 1, 2012
• First Posted: October 3, 2012
• Study Start: June 1, 2011
• Study Completion: October 1, 2012
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

US (2)