<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/NCT03230188</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0208</org_study_id>
    <secondary_id>5R01HL123284-02</secondary_id>
    <nct_id>NCT03230188</nct_id>
  </id_info>
  <brief_title>Patterns of Neurocircuitry Activation In Severe Asthma</brief_title>
  <acronym>PANISA</acronym>
  <official_title>Patterns of Neurocircuitry Activation In Severe Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of the study is to compare the patterns of neurocircuitry activation in&#xD;
      severe asthmatics vs. mild to moderate and healthy controls. The Investigators hypothesize&#xD;
      that neurocircuitry activation increases with asthma severity, producing different&#xD;
      neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or&#xD;
      non-asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To begin to further address possible relationships of asthma and brain function, the&#xD;
      investigators propose the following hypothesis, &quot;patients with defined characteristics of&#xD;
      severe asthma will have distinct patterns of persistent neurocircuitry activation. The&#xD;
      investigators further propose that the detection of ongoing neurocircuitry activation occurs&#xD;
      because of persistent and active airway inflammation in severe asthma. Finally, the&#xD;
      investigators propose that the intensity of specific neurocircuitry activation will relate to&#xD;
      the severity of underlying asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">June 17, 2018</completion_date>
  <primary_completion_date type="Actual">June 17, 2018</primary_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>
  <primary_outcome>
    <measure>Measures of Neural Activity</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>% signal change in brain insula detected by functional Magnetic Resonance Imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Airway Cellular and Molecular Inflammatory Response- White Blood Cells</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Cellular and Molecular Inflammatory Response- Eosinophils</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cell differential counts- Eosinophils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Cellular and Molecular Inflammatory Response- Lymphocytes</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway Cellular and Molecular Inflammatory Response- Neutrophils</measure>
    <time_frame>Visit 1 (1 day)</time_frame>
    <description>Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>Severe Asthmatics</arm_group_label>
    <description>Individuals with severe asthma that are already enrolled in the University of Wisconsin Severe Asthma Research Program III study will fill out asthma and psychological questionnaires (non-diagnostic), will undergo Cognitive Function Testing (non-diagnostic), and will undergo a simulated and actual functional Magnetic Resonance Imaging (research grade) scan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>functional Magnetic Resonance Imaging (research grade)</intervention_name>
    <description>Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.</description>
    <arm_group_label>Severe Asthmatics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive Function Testing (non-diagnostic)</intervention_name>
    <description>Subjects will take non-diagnostic cognitive function tests</description>
    <arm_group_label>Severe Asthmatics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Asthma and Psychological Questionnaires (non-diagnostic)</intervention_name>
    <description>Subjects will fill out asthma and psychological questionnaires (non-diagnostic)</description>
    <arm_group_label>Severe Asthmatics</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adults ages 18 and older who are currently rolled in the Severe Asthma Research Program III&#xD;
        study at the University of Wisconsin-Madison (all subjects have severe asthma)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in Severe Asthma Research Program III (2012-0571) study&#xD;
&#xD;
          -  Has severe asthma&#xD;
&#xD;
          -  Is a male or female with no health concerns that might affect the outcome of the study&#xD;
&#xD;
          -  Provided a negative urine pregnancy test prior to visit (Females only)&#xD;
&#xD;
          -  Capable and willing to grant written informed consent and cooperate with study&#xD;
             procedures and requirements (investigator discretion)&#xD;
&#xD;
          -  Is able to tolerate a simulated functional Magnetic Resonance Imaging brain scanning&#xD;
             session&#xD;
&#xD;
          -  Is able to give valid informed consent to participate by signing and dating a written&#xD;
             consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uses psychotropic medication that might affect function of neurocircuitry implicated&#xD;
             in our hypotheses (at the discretion of a study physician or Co-Investigator)&#xD;
&#xD;
          -  Has one or more contraindications for functional Magnetic Resonance Imaging&#xD;
&#xD;
          -  Has needle phobia or claustrophobia&#xD;
&#xD;
          -  Unable to distinguish specific colors used in Stroop task&#xD;
&#xD;
          -  History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder&#xD;
&#xD;
          -  Is a pregnant or lactating female&#xD;
&#xD;
          -  Has had an upper or lower respiratory infection within 1 month of the visit&#xD;
&#xD;
          -  Has unstable asthma as indicated by self-report of increased symptoms or increased&#xD;
             beta-agonist use over the 2 weeks preceding the visit&#xD;
&#xD;
          -  Is a current smoker (defined as smoked within the last year) or a former smoker with a&#xD;
             history of &gt;5 pack years&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigator, might interfere with&#xD;
             participation in the study&#xD;
&#xD;
          -  Inability or unwillingness to perform required study procedures&#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>William W Busse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Wisconsin School of Medicine and Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UW Madison</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>neurocircuitry</keyword>
  <keyword>severe asthma</keyword>
  <keyword>mild to moderate asthma</keyword>
  <keyword>neurocircuitry patterns</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT03230188/Prot_SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03230188
org study id: 2017-0208
secondary id: 5R01HL123284-02
nct id: NCT03230188
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall purpose of the study is to compare the patterns of neurocircuitry activation in
      severe asthmatics vs. mild to moderate and healthy controls. The Investigators hypothesize
      that neurocircuitry activation increases with asthma severity, producing different
      neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or
      non-asthmatics.
To begin to further address possible relationships of asthma and brain function, the
      investigators propose the following hypothesis, "patients with defined characteristics of
      severe asthma will have distinct patterns of persistent neurocircuitry activation. The
      investigators further propose that the detection of ongoing neurocircuitry activation occurs
      because of persistent and active airway inflammation in severe asthma. Finally, the
      investigators propose that the intensity of specific neurocircuitry activation will relate to
      the severity of underlying asthma.
observational model: Cohort
time perspective: Prospective
measure: Measures of Neural Activity
time frame: Visit 1 (1 day)
description: % signal change in brain insula detected by functional Magnetic Resonance Imaging
measure: Airway Cellular and Molecular Inflammatory Response- White Blood Cells
time frame: Visit 1 (1 day)
description: Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)
measure: Airway Cellular and Molecular Inflammatory Response- Eosinophils
time frame: Visit 1 (1 day)
description: Cell differential counts- Eosinophils
measure: Airway Cellular and Molecular Inflammatory Response- Lymphocytes
time frame: Visit 1 (1 day)
description: Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)
measure: Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages
time frame: Visit 1 (1 day)
description: Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)
measure: Airway Cellular and Molecular Inflammatory Response- Neutrophils
time frame: Visit 1 (1 day)
description: Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)
arm group label: Severe Asthmatics
description: Individuals with severe asthma that are already enrolled in the University of Wisconsin Severe Asthma Research Program III study will fill out asthma and psychological questionnaires (non-diagnostic), will undergo Cognitive Function Testing (non-diagnostic), and will undergo a simulated and actual functional Magnetic Resonance Imaging (research grade) scan.
intervention type: Other
intervention name: functional Magnetic Resonance Imaging (research grade)
description: Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.
arm group label: Severe Asthmatics
intervention type: Other
intervention name: Cognitive Function Testing (non-diagnostic)
description: Subjects will take non-diagnostic cognitive function tests
arm group label: Severe Asthmatics
intervention type: Other
intervention name: Asthma and Psychological Questionnaires (non-diagnostic)
description: Subjects will fill out asthma and psychological questionnaires (non-diagnostic)
arm group label: Severe Asthmatics
Blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William W Busse, MD
role: Principal Investigator
affiliation: The University of Wisconsin School of Medicine and Public Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
mesh term: Lung Diseases
sharing ipd: No
provided document: 