<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01698983</url>
  </required_header>
  <id_info>
    <org_study_id>2011H0055</org_study_id>
    <nct_id>NCT01698983</nct_id>
  </id_info>
  <brief_title>Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics</brief_title>
  <official_title>Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeanette Marketon, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gluococorticoids are commonly prescribed to treat a number of diseases including the majority&#xD;
      of inflammatory diseases. Despite considerable inter-personal variability in responses to&#xD;
      glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of&#xD;
      adverse side effects of glucocorticoid therapy, no assay is currently performed to determine&#xD;
      sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study&#xD;
      is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid&#xD;
      receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare&#xD;
      the results between severe and non-severe asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    data not as expected&#xD;
  </why_stopped>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <enrollment type="Actual">14</enrollment>
  <condition>Asthma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        To be eligible for the study, subjects must meet all of the following criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Physician diagnosis of asthma confirmed through medical record documentation.&#xD;
&#xD;
          -  Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine&#xD;
             PC 20 score of 16mg/ml or less.&#xD;
&#xD;
          -  Non-smoker for &gt; 6 months before enrollment into the trial&#xD;
&#xD;
          -  Less than 5 pack year smoking history defined as the average packs smoked per day&#xD;
             multiplied by the years of active smoking.&#xD;
&#xD;
          -  Willing and able to adhere to the study visit schedule and other protocol-specified&#xD;
             procedures.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        Subjects meeting any of the following criteria may not be enrolled in the study:&#xD;
&#xD;
          -  Existence of lung disease (other than asthma)&#xD;
&#xD;
          -  Recent asthma exacerbation requiring hospital admissions, unexpected healthcare&#xD;
             visits, or prednisone courses in the previous 4 weeks.&#xD;
&#xD;
          -  Non-English speaking.&#xD;
&#xD;
          -  Participation in another interventional research trial&#xD;
&#xD;
          -  Self-reported pregnancy&#xD;
&#xD;
          -  Inability or unwillingness to provide consent&#xD;
&#xD;
          -  Febrile illness (&gt;38.0˚ C or 100.4˚ F) within 24 hours of visit.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeanette Marketon, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Recruit and Consent Patients</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Martha Morehouse Medical Pavillion</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>432211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martha Morehouse Medical Pavillion</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Jeanette Marketon, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01698983
org study id: 2011H0055
nct id: NCT01698983
lead sponsor: 
has dmc: No
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.
observational model: Cohort
time perspective: Prospective
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jeanette Marketon, Ph.D.
role: Principal Investigator
affiliation: Recruit and Consent Patients
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Jeanette Marketon, MD
investigator title: Assistant Professor
mesh term: Asthma
mesh term: Hypersensitivity