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

Sponsor
Jeanette Marketon, MD (Other)
Overall Status
Terminated
CT.gov ID
NCT01698983
Collaborator
(none)
14
Enrollment
2
Locations
16
Duration (Months)
7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    14 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics
    Study Start Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Oct 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Martha Morehouse Medical Pavillion Columbus Ohio United States 432211
      2 Martha Morehouse Medical Pavillion Columbus Ohio United States 43221

      Sponsors and Collaborators

      • Jeanette Marketon, MD

      Investigators

      • Principal Investigator: Jeanette Marketon, Ph.D., Recruit and Consent Patients

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Jeanette Marketon, MD, Assistant Professor, Ohio State University
      ClinicalTrials.gov Identifier:
      NCT01698983
      Other Study ID Numbers:
      • 2011H0055
      First Posted:
      Oct 3, 2012
      Last Update Posted:
      Oct 31, 2012
      Last Verified:
      Oct 1, 2012
      Additional relevant MeSH terms:
      Asthma
      Hypersensitivity

      Study Results

      No Results Posted as of Oct 31, 2012