<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/NCT02241265</url>
  </required_header>
  <id_info>
    <org_study_id>3790</org_study_id>
    <secondary_id>3790</secondary_id>
    <nct_id>NCT02241265</nct_id>
  </id_info>
  <brief_title>Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma</brief_title>
  <official_title>Spirometric Response to Bronchial Thermoplasty in Patients With Severe Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</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 investigators hypothesis is that there will be improvement in FEV1 in patients with&#xD;
      severe asthma. This is a retrospective data study that reviews preexisting medical records;&#xD;
      no patients will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan is to retrospectively evaluate spirometry on patients with severe&#xD;
      asthma who have undergone bronchial thermoplasty. The procedure will have been done according&#xD;
      to the recommended protocol of three separate sessions. For each patient all available&#xD;
      spirometric data obtained before and after thermoplasty will be used. Data will be collected&#xD;
      from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures&#xD;
      done at St. Francis have been performed by a single physician and he is providing their&#xD;
      spirometric data for the investigators study. The following data will be collected for all&#xD;
      participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history,&#xD;
      smoking history, baseline spirometry before and after bronchodilators, post thermoplasty&#xD;
      spirometry before and after bronchodilators.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoints are improvements in prebronchodilator FEV1 and FVC.</measure>
    <time_frame>1 year after thermoplasty</time_frame>
    <description>The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.</measure>
    <time_frame>1 year after thermoplasty</time_frame>
    <description>Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Past Bronchial Thermoplasty data</arm_group_label>
    <description>Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Retrospective review of Asthma Patients' records&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years of age&#xD;
&#xD;
          -  severe asthma diagnosis&#xD;
&#xD;
          -  decreased FEV1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brent Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUHSC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OUHSC</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>May 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>November 21, 2019</last_update_submitted>
  <last_update_submitted_qc>November 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>asthma</keyword>
  <keyword>thermoplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.</ipd_description>
  </patient_data>
  <!-- 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/NCT02241265
org study id: 3790
secondary id: 3790
nct id: NCT02241265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators hypothesis is that there will be improvement in FEV1 in patients with
      severe asthma. This is a retrospective data study that reviews preexisting medical records;
      no patients will be enrolled.
The investigators plan is to retrospectively evaluate spirometry on patients with severe
      asthma who have undergone bronchial thermoplasty. The procedure will have been done according
      to the recommended protocol of three separate sessions. For each patient all available
      spirometric data obtained before and after thermoplasty will be used. Data will be collected
      from two centers, OU Medical Center and St. Francis Hospital in Tulsa, OK. All procedures
      done at St. Francis have been performed by a single physician and he is providing their
      spirometric data for the investigators study. The following data will be collected for all
      participants undergoing bronchial thermoplasty: Age, height, sex, weight, medical history,
      smoking history, baseline spirometry before and after bronchodilators, post thermoplasty
      spirometry before and after bronchodilators.
observational model: Case-Only
time perspective: Retrospective
measure: The primary endpoints are improvements in prebronchodilator FEV1 and FVC.
time frame: 1 year after thermoplasty
description: The primary endpoints are improvements in prebronchodilator FEV1 and FVC by 12% predicted.
measure: Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness.
time frame: 1 year after thermoplasty
description: Secondary endpoints are improvements in postbronchodilator FEV1 and FVC and degree of bronchodilator responsiveness by 12% predicted.
arm group label: Past Bronchial Thermoplasty data
description: Data will be collected from records of patients who, in the past, have undergone bronchial thermoplasty.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Brent Brown, MD
role: Principal Investigator
affiliation: OUHSC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
ipd description: Deidentified data may only be shared upon review of OUHSC Legal office and IRB. Data sharing agreement required. Contact research@ouhsc.edu to initiate data requests. No personally identifiable data will be shared.