<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/NCT02225678</url>
  </required_header>
  <id_info>
    <org_study_id>14-001168</org_study_id>
    <nct_id>NCT02225678</nct_id>
  </id_info>
  <brief_title>Minimally Invasive Biomarker for Asthma Disease Severity</brief_title>
  <official_title>Feasibility of Using an Eosinophil-Specific Biomarker-(Eosinophil Peroxidase) in Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Can a clinical test be developed that could help manage asthma symptoms?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project goals:&#xD;
&#xD;
      Develop a point-of-service assay to assess eosinophilic airway inflammation&#xD;
&#xD;
      Proposal Specific Aims:&#xD;
&#xD;
        1. To establish the infrastructure and test the feasibility of sputum collection in a&#xD;
           clinical setting as a minimally invasive patient sampling process for biomarker testing&#xD;
&#xD;
        2. To transform the laboratory-based eosinophil peroxidase (EPX) ELISA detection assay into&#xD;
           a clinic-friendly assessment that does not require sophisticated laboratory equipment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sputum Induction</measure>
    <time_frame>10 minutes</time_frame>
    <description>Primary Outcome measure via EPX levels (at point of care) in the sputum of asthma patients and control subjects as a means of demonstrating the ability to use this biomarker approach in a clinical setting.</description>
  </primary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Asthma</condition>
  <condition>Healthy</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      sputum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        asthma patients healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Asthma subjects:&#xD;
&#xD;
        Inclusion&#xD;
&#xD;
          -  Provider diagnosed asthma&#xD;
&#xD;
          -  FeNO&gt;50 ppb&#xD;
&#xD;
          -  FEV1 &gt; 1.0 Liter&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  COPD by history&#xD;
&#xD;
          -  Bronchiectasis by history&#xD;
&#xD;
          -  Pregnant participants&#xD;
&#xD;
        Normal subjects:&#xD;
&#xD;
        Inclusion&#xD;
&#xD;
        - Age matched to asthma subjects&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Any eosinophil disorder by history&#xD;
&#xD;
          -  Asthma by history&#xD;
&#xD;
          -  Rhinitis or sinusitis by history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Lee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>May 13, 2016</last_update_submitted>
  <last_update_submitted_qc>May 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>James J. Lee, Ph.D.</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <keyword>healthy volunteers</keyword>
  <keyword>asthma</keyword>
  <keyword>sputum eosinophils</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02225678
org study id: 14-001168
nct id: NCT02225678
lead sponsor: 
has dmc: No
Can a clinical test be developed that could help manage asthma symptoms?
Project goals:

      Develop a point-of-service assay to assess eosinophilic airway inflammation

      Proposal Specific Aims:

        1. To establish the infrastructure and test the feasibility of sputum collection in a
           clinical setting as a minimally invasive patient sampling process for biomarker testing

        2. To transform the laboratory-based eosinophil peroxidase (EPX) ELISA detection assay into
           a clinic-friendly assessment that does not require sophisticated laboratory equipment
observational model: Case-Control
time perspective: Prospective
measure: Sputum Induction
time frame: 10 minutes
description: Primary Outcome measure via EPX levels (at point of care) in the sputum of asthma patients and control subjects as a means of demonstrating the ability to use this biomarker approach in a clinical setting.
sputum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James Lee, PhD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: James J. Lee, Ph.D.
investigator title: PI
mesh term: Asthma