<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/NCT02998515</url>
  </required_header>
  <id_info>
    <org_study_id>ACT2016</org_study_id>
    <nct_id>NCT02998515</nct_id>
  </id_info>
  <brief_title>Effects of Different Oxygen Devices in Hypoxemic COPD Patients</brief_title>
  <official_title>Effects of Supplemental Oxygen Delivery Via Portable Oxygen Concentrator (Activox™4L) vs. Liquid Oxygen Device in Hypoxemic COPD Patients - a Non-inferiority Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schön Klinik Berchtesgadener Land</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Schön Klinik Berchtesgadener Land</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Taken recent literature together, there is a sufficient number of trials investigating the&#xD;
      effect of different oxygen devices. However, studies comparing oxygen delivery via portable&#xD;
      oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing&#xD;
      and sufficient power are missing.&#xD;
&#xD;
      Given that walking is the most important activity of daily life to preserve the maintenance&#xD;
      and to participate in social life, we aim to investigate the effects of two different oxygen&#xD;
      delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).&#xD;
&#xD;
      The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking&#xD;
      capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT&#xD;
      is that the ESWT is performed at 85% of the individual maximum which is close to the&#xD;
      intensity of typical daily activities. Due to the fact that the ESWT enables us to determine&#xD;
      the maximum duration of exercise and to compare values at isotime (at the point of time when&#xD;
      the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)</measure>
    <time_frame>Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)</time_frame>
    <description>ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Breathing frequency</measure>
    <time_frame>Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)</time_frame>
    <description>ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Inspiratory capacity</measure>
    <time_frame>Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)</time_frame>
    <description>ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.&#xD;
Inspiratory capacity will be measured by a mobile spirometry (SpiroPalm mask).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endurance shuttle walk distance</measure>
    <time_frame>at the end of ESWT (until exhaustion, max. 20 minutes)</time_frame>
    <description>ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceived Dyspnea</measure>
    <time_frame>Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)</time_frame>
    <description>ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. Dyspnea will be rated by the Patient on a 10-point Borg scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in partial pressure of carbon dioxide</measure>
    <time_frame>Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)</time_frame>
    <description>ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease Severe</condition>
  <arm_group>
    <arm_group_label>ESWT order: 1.liquid oxygen, 2. concentrator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a portable liquid Oxygen device (Companion) and continue on the day after with ESWT by using supplemental Oxygen from a portable concentrator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESWT order: 1. concentrator, 2. liquid oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a concentrator and continue on the day after with ESWT by using supplemental Oxygen from a portable liquid Oxygen device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Companion (Liquid oxygen device)</intervention_name>
    <arm_group_label>ESWT order: 1. concentrator, 2. liquid oxygen</arm_group_label>
    <arm_group_label>ESWT order: 1.liquid oxygen, 2. concentrator</arm_group_label>
    <other_name>Device: Companion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activox (concentrator)</intervention_name>
    <arm_group_label>ESWT order: 1. concentrator, 2. liquid oxygen</arm_group_label>
    <arm_group_label>ESWT order: 1.liquid oxygen, 2. concentrator</arm_group_label>
    <other_name>Device: Activox</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients (GOLD stage III to IV) with hypoxemia at rest or during exercise&#xD;
             (paO2&lt;60mmHg)&#xD;
&#xD;
          -  Participation in an inpatient pulmonary rehabilitation program (Schön Klinik BGL)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute&#xD;
             myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled&#xD;
             heart insufficiency&#xD;
&#xD;
          -  Signs of acute exacerbation&#xD;
&#xD;
          -  Any orthopedic or neurological disabilities that prevent patient from walking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Schön Klinik Berchtesgadener Land</name>
      <address>
        <city>Schonau am Konigssee</city>
        <zip>83471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schön Klinik Berchtesgadener Land</investigator_affiliation>
    <investigator_full_name>Klaus Kenn</investigator_full_name>
    <investigator_title>Head physician of the department of Pneumology</investigator_title>
  </responsible_party>
  <keyword>supplemental oxygen</keyword>
  <keyword>concentrator</keyword>
  <keyword>endurance shuttle walk test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02998515
org study id: ACT2016
nct id: NCT02998515
lead sponsor: 
collaborator: 
has dmc: No
Taken recent literature together, there is a sufficient number of trials investigating the
      effect of different oxygen devices. However, studies comparing oxygen delivery via portable
      oxygen concentrator (POC) and liquid oxygen device (LOD) with appropriate exercise testing
      and sufficient power are missing.

      Given that walking is the most important activity of daily life to preserve the maintenance
      and to participate in social life, we aim to investigate the effects of two different oxygen
      delivery systems during walking in hypoxemic COPD patients (POC vs. LOD).

      The endurance shuttle walk test (ESWT) is well validated for measuring endurance walking
      capacity in COPD patients with good repeatability. The advantage of this test over the 6MWT
      is that the ESWT is performed at 85% of the individual maximum which is close to the
      intensity of typical daily activities. Due to the fact that the ESWT enables us to determine
      the maximum duration of exercise and to compare values at isotime (at the point of time when
      the shortest of the 3 ESWTs ends), we use the ESWT as exercise test in our trial.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in oxygen Saturation during endurance shuttle walk test (ESWT) compared between POC (concentrator) and LOD (liquid oxygen)
time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
description: ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.
measure: Change in Breathing frequency
time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
description: ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.
measure: Change in Inspiratory capacity
time frame: Change from baseline to the individual end of ESWT(until exhaustion, max. 20 minutes)
description: ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.
Inspiratory capacity will be measured by a mobile spirometry (SpiroPalm mask).
measure: Endurance shuttle walk distance
time frame: at the end of ESWT (until exhaustion, max. 20 minutes)
description: ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity.
measure: Change in perceived Dyspnea
time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
description: ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT. Dyspnea will be rated by the Patient on a 10-point Borg scale.
measure: Change in partial pressure of carbon dioxide
time frame: Change from baseline to the individual end of ESWT (until exhaustion, max. 20 minutes)
description: ESWT is designed to assess the Maximum Walking Duration that can be sustained at 85% of individual Maximum capacity. Therefore, outcome Parameter will also be assessed at the individual end of the ESWT.
arm group label: ESWT order: 1.liquid oxygen, 2. concentrator
arm group type: Experimental
description: Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a portable liquid Oxygen device (Companion) and continue on the day after with ESWT by using supplemental Oxygen from a portable concentrator.
arm group label: ESWT order: 1. concentrator, 2. liquid oxygen
arm group type: Experimental
description: Patients will start with the endurance shuttle walk test (ESWT) by using supplemental Oxygen from a concentrator and continue on the day after with ESWT by using supplemental Oxygen from a portable liquid Oxygen device.
intervention type: Device
intervention name: Companion (Liquid oxygen device)
arm group label: ESWT order: 1. concentrator, 2. liquid oxygen
arm group label: ESWT order: 1.liquid oxygen, 2. concentrator
other name: Device: Companion
intervention type: Device
intervention name: Activox (concentrator)
arm group label: ESWT order: 1. concentrator, 2. liquid oxygen
arm group label: ESWT order: 1.liquid oxygen, 2. concentrator
other name: Device: Activox
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Klaus Kenn
investigator title: Head physician of the department of Pneumology
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Undecided