<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/NCT04452851</url>
  </required_header>
  <id_info>
    <org_study_id>R44HL154932</org_study_id>
    <nct_id>NCT04452851</nct_id>
  </id_info>
  <brief_title>Portable Positive Pressure Therapy Device</brief_title>
  <official_title>Portable Non-invasive Positive Pressure Airway Device Therapy System Efficacy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Koronis Biomedical Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Koronis Biomedical Technologies</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the impact the BREATHE device provides on post-exertion recovery time&#xD;
      in COPD patients when used during and/or after performing an Activity of Daily Living&#xD;
      simulation. It will also establish equivalency with BiPAP machines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Overview: Potential subjects who are clinically stable COPD patients with 30% ≤ FEV1 &lt;&#xD;
      50% (COPD GOLD criteria stage 3), will be enrolled. Following consent procedures, interested&#xD;
      participants will be screened for eligibility. Eligible subjects will be invited to the test&#xD;
      facility for four (4) visits. During the first visit, baseline measurements will be made. In&#xD;
      the subsequent three (3) sessions, subjects will be asked to perform two (2) tests (BiPAP&#xD;
      Equivalency Test and Activity of Daily Living Simulation). Baseline evaluation techniques&#xD;
      will include spirometry, a Six Minute Walk Test (6MWT) (which produces a Six Minute Walk&#xD;
      Distance, or 6MWD), and finally, a baseline treadmill test. Prior to the baseline treadmill&#xD;
      test, Borg Scores will be measured. The subjects will then be asked to walk at a comfortable&#xD;
      speed on the treadmill. The incline will be increased each minute by either 1% (Baseline 6MWD&#xD;
      &lt; 250m) or 2% (Baseline 6MWD &gt;250m) until they reached a Borg score of 7.&#xD;
&#xD;
      In subsequent visits, subjects will be randomly assigned each of six tests including:&#xD;
      treadmill tests that repeat the baseline treadmill test with a) the prototype BREATHE device,&#xD;
      b) a standard BiPAP system, or c) a placebo inhaler used during recovery; and Glittre ADL&#xD;
      tests where the subject either has access to the BREATHE device a) withheld, b) during&#xD;
      recovery, and c) during test performance and recovery. The primary endpoint in each of these&#xD;
      tests is the recovery time (return to 0 Borg, &quot;No difficulty breathing&quot;). SpO2, heart rate,&#xD;
      respiration rate, and total test times will also be recorded during each test.&#xD;
&#xD;
      BiPAP Equivalency Test: Subjects will perform exercise tests identical to the treadmill tests&#xD;
      from the baseline test. However, in these tests, after they reach a Borg score of 7, they&#xD;
      will be allowed to recover with a) the prototype BREATHE system, b) a standard BiPAP machine,&#xD;
      and c) a placebo inhaler until they are fully recovered (Borg: 0).&#xD;
&#xD;
      Activity of Daily Living Simulation: Subjects will be asked to complete Glittre-ADL tests.&#xD;
      This test is a standard COPD functional performance instrument. At the beginning of each&#xD;
      test, participants will be instructed to rise from a chair and walk 10 meters, ascending a&#xD;
      2-step rise about half-way along that distance, to reach a shelving unit. The shelves will be&#xD;
      positioned at shoulder and waist height. The participant will move 3 cartons, each weighing 1&#xD;
      kg, from the upper to the lower shelf and then to the floor.&#xD;
&#xD;
      The sequence is then reversed so that each carton is returned to the top shelf before the&#xD;
      participant returns to the starting position at the chair. At that time the participant sits&#xD;
      down and then immediately rises to begin the next lap. The test ends when the participant&#xD;
      completes 5 of these laps. Participants are told to perform the test as quickly as possible.&#xD;
      Rests are allowed but participants are told to resume activity as soon as possible. During&#xD;
      the test, participants will wear a backpack filled with a 2.5 (women) or 5 kg (men) weight.&#xD;
      The 2.5 kg weight simulates the weight of a supplemental oxygen unit, which can be exchanged&#xD;
      for the weight when appropriate. This allows the addition of oxygen for future tests without&#xD;
      affecting the integrity of the test.&#xD;
&#xD;
      Three different Glittre-ADL tests will be completed. In these sessions, the BREATHE system&#xD;
      will a) not be available, b) be available for use during post-exertion recovery, and c) be&#xD;
      available for use throughout the test and recovery period. Borg scores will be measured after&#xD;
      each minute of exercise and every 30 seconds during seated recovery until the subject is&#xD;
      fully recovered (Borg: 0).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2022</start_date>
  <completion_date type="Anticipated">August 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Subjects will be asked to participate in four (4) visits. During the first visit, baseline measurements will be made. In the subsequent three (3) sessions, subjects will be asked to perform two (2) tests from a group of six (6) options. This list of tests is comprised of three BiPAP Equivalency tests and three Activity of Daily Living Simulations. Participants will be randomized to study groups using a table of random numbers generated at the outset of the study to determine the test order.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery Time</measure>
    <time_frame>30 minutes</time_frame>
    <description>The time it takes to return to 0 on the Borg Dyspnoea Scale (&quot;No difficulty breathing&quot;) following exercise. This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Treadmill test with BREATHE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with the prototype BREATHE system until they are fully recovered (Borg: 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill test with BiPAP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with a standard BiPAP machine until they are fully recovered (Borg: 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treadmill test with placebo inhaler</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with a placebo inhaler until they are fully recovered (Borg: 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity of Daily Living with BREATHE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be asked to complete Glittre-ADL tests with the BREATHE system being available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity of Daily Living with BREATHE during recovery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will be asked to complete Glittre-ADL tests with the BREATHE system being available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Activity of Daily Living</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects will be asked to complete Glittre-ADL tests with the BREATHE system will NOT be available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BREATHE</intervention_name>
    <description>The on-demand handheld portable noninvasive positive pressure airway device unit generates BiPAP by using a built-in blower which intakes air from the nearby ambient. The BiPAP pressure functions as a virtual stent within the lungs of a user with COPD. The virtual stent opens the passageways within the user lungs. Once opened, the virtual stent facilitates gas exchange in order to relieve dyspnea. By temporarily facilitating this gas exchange, the user will quickly recover from dyspnea in order to resume regular activities.</description>
    <arm_group_label>Activity of Daily Living with BREATHE</arm_group_label>
    <arm_group_label>Activity of Daily Living with BREATHE during recovery</arm_group_label>
    <arm_group_label>Treadmill test with BREATHE</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiPAP</intervention_name>
    <description>BiPAP stands for Bilevel Positive Airway Pressure, and is very similar in function and design to a CPAP machine (continuous positive airway pressure). A BiPAP machine is a non-invasive form of therapy for patients suffering from sleep apnea.</description>
    <arm_group_label>Treadmill test with BiPAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>COPD Inhaler</intervention_name>
    <description>Inhaler medication to support quick relief from COPD symptoms</description>
    <arm_group_label>Treadmill test with placebo inhaler</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is age 21 to 85&#xD;
&#xD;
          -  Clinically stable&#xD;
&#xD;
          -  Diagnosis of COPD following ERS-ATS guidelines 2011 update with GOLD criteria stage 3&#xD;
             (&quot;Severe&quot;), 30% ≤ FEV1 &lt; 50%&#xD;
&#xD;
          -  Capable of giving informed consent&#xD;
&#xD;
          -  Willing and able to comply with the test program as directed by staff.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is not fluent in written or spoken English&#xD;
&#xD;
          -  Has physical impairment that prevents the subject from being able to walk or stand&#xD;
&#xD;
          -  Is acutely ill/medically complicated, as determined by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Knuesel, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Koronis Biomedical Technologies</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick Lichter</last_name>
    <phone>6127301091</phone>
    <email>plichter@koronisbiotech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Robert Knuesel, PhD</last_name>
    <phone>(507) 459-8625</phone>
    <email>rknuesel@koronisbiotech.com</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04452851
org study id: R44HL154932
nct id: NCT04452851
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
This study will assess the impact the BREATHE device provides on post-exertion recovery time
      in COPD patients when used during and/or after performing an Activity of Daily Living
      simulation. It will also establish equivalency with BiPAP machines.
Study Overview: Potential subjects who are clinically stable COPD patients with 30% ≤ FEV1 <
      50% (COPD GOLD criteria stage 3), will be enrolled. Following consent procedures, interested
      participants will be screened for eligibility. Eligible subjects will be invited to the test
      facility for four (4) visits. During the first visit, baseline measurements will be made. In
      the subsequent three (3) sessions, subjects will be asked to perform two (2) tests (BiPAP
      Equivalency Test and Activity of Daily Living Simulation). Baseline evaluation techniques
      will include spirometry, a Six Minute Walk Test (6MWT) (which produces a Six Minute Walk
      Distance, or 6MWD), and finally, a baseline treadmill test. Prior to the baseline treadmill
      test, Borg Scores will be measured. The subjects will then be asked to walk at a comfortable
      speed on the treadmill. The incline will be increased each minute by either 1% (Baseline 6MWD
      < 250m) or 2% (Baseline 6MWD >250m) until they reached a Borg score of 7.

      In subsequent visits, subjects will be randomly assigned each of six tests including:
      treadmill tests that repeat the baseline treadmill test with a) the prototype BREATHE device,
      b) a standard BiPAP system, or c) a placebo inhaler used during recovery; and Glittre ADL
      tests where the subject either has access to the BREATHE device a) withheld, b) during
      recovery, and c) during test performance and recovery. The primary endpoint in each of these
      tests is the recovery time (return to 0 Borg, "No difficulty breathing"). SpO2, heart rate,
      respiration rate, and total test times will also be recorded during each test.

      BiPAP Equivalency Test: Subjects will perform exercise tests identical to the treadmill tests
      from the baseline test. However, in these tests, after they reach a Borg score of 7, they
      will be allowed to recover with a) the prototype BREATHE system, b) a standard BiPAP machine,
      and c) a placebo inhaler until they are fully recovered (Borg: 0).

      Activity of Daily Living Simulation: Subjects will be asked to complete Glittre-ADL tests.
      This test is a standard COPD functional performance instrument. At the beginning of each
      test, participants will be instructed to rise from a chair and walk 10 meters, ascending a
      2-step rise about half-way along that distance, to reach a shelving unit. The shelves will be
      positioned at shoulder and waist height. The participant will move 3 cartons, each weighing 1
      kg, from the upper to the lower shelf and then to the floor.

      The sequence is then reversed so that each carton is returned to the top shelf before the
      participant returns to the starting position at the chair. At that time the participant sits
      down and then immediately rises to begin the next lap. The test ends when the participant
      completes 5 of these laps. Participants are told to perform the test as quickly as possible.
      Rests are allowed but participants are told to resume activity as soon as possible. During
      the test, participants will wear a backpack filled with a 2.5 (women) or 5 kg (men) weight.
      The 2.5 kg weight simulates the weight of a supplemental oxygen unit, which can be exchanged
      for the weight when appropriate. This allows the addition of oxygen for future tests without
      affecting the integrity of the test.

      Three different Glittre-ADL tests will be completed. In these sessions, the BREATHE system
      will a) not be available, b) be available for use during post-exertion recovery, and c) be
      available for use throughout the test and recovery period. Borg scores will be measured after
      each minute of exercise and every 30 seconds during seated recovery until the subject is
      fully recovered (Borg: 0).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Subjects will be asked to participate in four (4) visits. During the first visit, baseline measurements will be made. In the subsequent three (3) sessions, subjects will be asked to perform two (2) tests from a group of six (6) options. This list of tests is comprised of three BiPAP Equivalency tests and three Activity of Daily Living Simulations. Participants will be randomized to study groups using a table of random numbers generated at the outset of the study to determine the test order.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Recovery Time
time frame: 30 minutes
description: The time it takes to return to 0 on the Borg Dyspnoea Scale ("No difficulty breathing") following exercise. This is a scale that asks you to rate the difficulty of your breathing. It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.
arm group label: Treadmill test with BREATHE
arm group type: Experimental
description: Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with the prototype BREATHE system until they are fully recovered (Borg: 0).
arm group label: Treadmill test with BiPAP
arm group type: Active Comparator
description: Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with a standard BiPAP machine until they are fully recovered (Borg: 0).
arm group label: Treadmill test with placebo inhaler
arm group type: Placebo Comparator
description: Subjects will perform exercise tests identical to the treadmill tests from the baseline test. However, in this test, after they reach a Borg score of 7, they will be allowed to recover with a placebo inhaler until they are fully recovered (Borg: 0).
arm group label: Activity of Daily Living with BREATHE
arm group type: Experimental
description: Subjects will be asked to complete Glittre-ADL tests with the BREATHE system being available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).
arm group label: Activity of Daily Living with BREATHE during recovery
arm group type: Experimental
description: Subjects will be asked to complete Glittre-ADL tests with the BREATHE system being available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).
arm group label: Activity of Daily Living
arm group type: No Intervention
description: Subjects will be asked to complete Glittre-ADL tests with the BREATHE system will NOT be available for use throughout the test and recovery period. Borg scores will be measured after each minute of exercise and every 30 seconds during seated recovery until the subject is fully recovered (Borg: 0).
intervention type: Device
intervention name: BREATHE
description: The on-demand handheld portable noninvasive positive pressure airway device unit generates BiPAP by using a built-in blower which intakes air from the nearby ambient. The BiPAP pressure functions as a virtual stent within the lungs of a user with COPD. The virtual stent opens the passageways within the user lungs. Once opened, the virtual stent facilitates gas exchange in order to relieve dyspnea. By temporarily facilitating this gas exchange, the user will quickly recover from dyspnea in order to resume regular activities.
arm group label: Activity of Daily Living with BREATHE
arm group label: Activity of Daily Living with BREATHE during recovery
arm group label: Treadmill test with BREATHE
intervention type: Device
intervention name: BiPAP
description: BiPAP stands for Bilevel Positive Airway Pressure, and is very similar in function and design to a CPAP machine (continuous positive airway pressure). A BiPAP machine is a non-invasive form of therapy for patients suffering from sleep apnea.
arm group label: Treadmill test with BiPAP
intervention type: Drug
intervention name: COPD Inhaler
description: Inhaler medication to support quick relief from COPD symptoms
arm group label: Treadmill test with placebo inhaler
criteria: 
gender: All
minimum age: 21 Years
maximum age: 85 Years
healthy volunteers: No
last name: Robert Knuesel, PhD
role: Principal Investigator
affiliation: Koronis Biomedical Technologies
last name: Patrick Lichter
phone: 6127301091
email: plichter@koronisbiotech.com
last name: Robert Knuesel, PhD
phone: (507) 459-8625
email: rknuesel@koronisbiotech.com
responsible party type: Sponsor
sharing ipd: No