<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/NCT03267992</url>
  </required_header>
  <id_info>
    <org_study_id>CLN0020</org_study_id>
    <nct_id>NCT03267992</nct_id>
  </id_info>
  <brief_title>Chronic Obstructive Pulmonary Disease (COPD) Co-Pilot AIR Substudy of CLN0014</brief_title>
  <acronym>Co-Pilot Air</acronym>
  <official_title>Observational Study of HGE Health Care Solution COPD Co-Pilot AIR™ Application in Subjects Undergoing the PneumRx® Endobronchial Coil Procedure as Part of EU Registry CLN0014</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PneumRx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Scientific Corporation</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 purpose of undertaking CLN0020, which was a Substudy of the European Coil registry&#xD;
      (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management&#xD;
      program manufactured and operated by HGE Health Care Solutions, LLC, in participants&#xD;
      undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application&#xD;
      (an &quot;app&quot;) with facilitation of rapid personalized clinical recommendations made by the&#xD;
      participant's health care provider and communicated to the participant through the&#xD;
      application. COPD Co-Pilot AIR™ provides early identification of an increase in a&#xD;
      participant's respiratory symptoms relative to the participant's own baseline symptom profile&#xD;
      which in turn enables health care providers to rapidly implement modified treatment plans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study enrollment was prematurely stopped for business reasons.&#xD;
  </why_stopped>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">October 20, 2018</completion_date>
  <primary_completion_date type="Actual">October 20, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Rate of COPD Exacerbation</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of COPD Exacerbation serious adverse events (SAEs) reported in the 12-month period following the initial Endobronchial Coil procedure for participants enrolled in CLN0020 when compared to CLN0014 participant population that was not managed utilizing COPD Co-Pilot AIR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory Related SAEs</measure>
    <time_frame>12 months</time_frame>
    <description>Percent of participants experiencing one or more respiratory-related SAEs in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants in CLN0014.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of First Respiratory-Related SAEs</measure>
    <time_frame>12 months</time_frame>
    <description>Rate of first respiratory-related SAEs reported in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Respiratory-Related SAE</measure>
    <time_frame>12 months</time_frame>
    <description>Time to first respiratory-related SAE following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.</description>
  </secondary_outcome>
  <enrollment type="Actual">9</enrollment>
  <condition>COPD Symptoms After Coil Procedure</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>COPD Co-Pilot AIR App</intervention_name>
    <description>App. For COPD symptoms after Coil procedure</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with COPD undergoing the PneumRx Endobronchial Coil Treatment in a post-market&#xD;
        setting.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participant has read, understood, and signed a CLN0020 informed consent form prior to&#xD;
             enrollment.&#xD;
&#xD;
          2. Participant is appropriate for Coil treatment per the Conformité Européene (European&#xD;
             Conformity [CE])-Mark Approved RePneu Instructions for Use (IFU).&#xD;
&#xD;
          3. Participant has been enrolled in and scheduled for treatment(s) with the PneumRx&#xD;
             Endobronchial Coil procedure in the CLN0014 study.&#xD;
&#xD;
          4. Participant's PneumRx Endobronchial Coil procedure is scheduled to occur no fewer than&#xD;
             14 days from enrollment, providing enough time to establish a baseline of their daily&#xD;
             symptoms. Ten days minimum of baseline data are required, which is defined as the&#xD;
             Run-in period going forward.&#xD;
&#xD;
          5. Participant is willing and able to use a smart phone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participant has undergone a Coil procedure.&#xD;
&#xD;
          2. Participant has had an acute exacerbation of COPD that required hospitalization or&#xD;
             emergency room visit or treatment with systemic steroids and/or antibiotics during the&#xD;
             28 days prior to CLN0020 enrollment.&#xD;
&#xD;
          3. Participant has a COPD exacerbation or respiratory illness during the Run-in period&#xD;
             that in the judgment of the investigator requires medical intervention (for example,&#xD;
             treatment with systemic steroids and/or antibiotics and/or hospitalization).&#xD;
&#xD;
          4. Participant is suffering from terminal illness expected to adversely affect survival&#xD;
             in the next 12 months.&#xD;
&#xD;
          5. Participant has a history of non-compliance with medical therapies.&#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>Daniel Franzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik für Pneumologie, Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève (HUG) Service</name>
      <address>
        <city>Genève</city>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitätsSpital</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>July 15, 2021</last_update_submitted>
  <last_update_submitted_qc>July 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Coils</keyword>
  <keyword>App</keyword>
  <!-- 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/NCT03267992
org study id: CLN0020
nct id: NCT03267992
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of undertaking CLN0020, which was a Substudy of the European Coil registry
      (CLN0014), was to investigate the use of COPD Co-Pilot AIR™, a COPD disease management
      program manufactured and operated by HGE Health Care Solutions, LLC, in participants
      undergoing the PneumRx Endobronchial Coil Treatment in a post-market setting.
COPD Co-Pilot AIR™ combines a digital respiratory symptom reporting participant application
      (an "app") with facilitation of rapid personalized clinical recommendations made by the
      participant's health care provider and communicated to the participant through the
      application. COPD Co-Pilot AIR™ provides early identification of an increase in a
      participant's respiratory symptoms relative to the participant's own baseline symptom profile
      which in turn enables health care providers to rapidly implement modified treatment plans.
observational model: Case-Only
time perspective: Other
measure: Rate of COPD Exacerbation
time frame: 12 months
description: Rate of COPD Exacerbation serious adverse events (SAEs) reported in the 12-month period following the initial Endobronchial Coil procedure for participants enrolled in CLN0020 when compared to CLN0014 participant population that was not managed utilizing COPD Co-Pilot AIR.
measure: Respiratory Related SAEs
time frame: 12 months
description: Percent of participants experiencing one or more respiratory-related SAEs in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants in CLN0014.
measure: Rate of First Respiratory-Related SAEs
time frame: 12 months
description: Rate of first respiratory-related SAEs reported in the 12-month period following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.
measure: Time to First Respiratory-Related SAE
time frame: 12 months
description: Time to first respiratory-related SAE following the initial Coil procedure comparing participants enrolled in CLN0020 to non-COPD Co-Pilot AIR participants enrolled in CLN0014.
intervention type: Behavioral
intervention name: COPD Co-Pilot AIR App
description: App. For COPD symptoms after Coil procedure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Franzen, MD
role: Principal Investigator
affiliation: Klinik für Pneumologie, Zurich
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor