<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/NCT01673685</url>
  </required_header>
  <id_info>
    <org_study_id>2010090</org_study_id>
    <nct_id>NCT01673685</nct_id>
  </id_info>
  <brief_title>Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators</brief_title>
  <official_title>Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Queen Elizabeth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Queen Elizabeth Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to&#xD;
      improve quality of life and other outcomes for patients with chronic obstructive pulmonary&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many patients with Chronic Obstructive Pulmonary Disease (COPD) have limited activities of&#xD;
      daily living (shopping, visiting friends, going for a walk) due to exertional dyspnoea. State&#xD;
      Government funding provides up to 4 oxygen cylinders to be delivered to patients requiring&#xD;
      portable oxygen per month. However, the more active and motivated COPD patients often find&#xD;
      these gratis supplies run out well before the month is up. Recent technology has developed&#xD;
      battery powered portable oxygen concentrators. The latest models weigh less than a typical&#xD;
      oxygen cylinder and have the advantage that the battery plug can be plugged into a car&#xD;
      cigarette lighter outlet, or into the power point of any house. This means that the COPD&#xD;
      patient has the potential to be far more mobile for far longer periods of time and visit&#xD;
      friends almost infinitely by recharging the battery pack during the course of their travels.&#xD;
      The latest battery powered oxygen device weighs 2kgs which is about half that of an oxygen&#xD;
      cylinder. However, there is an upfront expense to these devices and inevitably a sound&#xD;
      business case with cost considerations (amortization of the initial purchase price,&#xD;
      recharging the battery costing the patient's electricity etc) needs consideration. Also,&#xD;
      before assuming these devices are superior (or at least as good as) oxygen cylinders, because&#xD;
      they have a pulsed delivery of oxygen technology i.e. the oxygen is delivered in bursts with&#xD;
      each inspiration that is detected, unlike oxygen cylinders which can run continuously, one&#xD;
      cannot assume without rigorous evaluation that mobility and quality of life necessarily is&#xD;
      good or superior with the new devices. Hence, quality of life evaluation with emphasis on&#xD;
      enjoyed activities by each COPD patient are essential as well as costing issues for the&#xD;
      funding stakeholder (i.e. hospital site specific funds). Should a sound business case be made&#xD;
      (i.e. improved quality of life with less costs over a longer period of time), then a sound&#xD;
      justification can be made to funding bodies that COPD patients are better off and the funding&#xD;
      body is shouldering less cost by wider usage of these devices following evaluation of this&#xD;
      project. The design will be a randomised crossover such that COPD patients will spend one&#xD;
      month on oxygen or battery powered concentrator devices and then switch over to the other&#xD;
      oxygen delivery. Chronic Respiratory Questionnaire (Quality of Life) will be administered at&#xD;
      the end of each month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Portable oxygen concentrators vs oxygen cylinders</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life as measured through Chronic Respiratory Questionnaire</measure>
    <time_frame>One month</time_frame>
    <description>only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Preference</measure>
    <time_frame>One month</time_frame>
    <description>Five 7-point Likert Scales, ranging from 1 (none of the time) to 7 (all of the time) on portability (&quot;the equipment was portable enough for my needs&quot;), operation (&quot;I was able to set up and operate the equipment properly&quot;), noise (&quot;Noise from the equipment affected me&quot;), comprehension (&quot;I was able to understand the functions of the equipment, e.g. alarms&quot;) and duration (&quot;The oxygen lasted long enough for me to perform my normal activities&quot;). Furthermore, patients were asked to provide comments on use of the POCs and the Cylinders after they completed the respective stage of the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness of portable oxygen concentrator compared to cylinder</measure>
    <time_frame>one month</time_frame>
    <description>Economic assessment based on treatment cost, readmission data and hospital utilisation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as measured through AQoL-8D</measure>
    <time_frame>One month</time_frame>
    <description>Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility Instrument</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Portable Oxygen Cylinder</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Portable Oxygen Cylinder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Portable Oxygen Concentrator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Portable Oxygen Concentrator</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Portable Oxygen</intervention_name>
    <arm_group_label>Portable Oxygen Concentrator</arm_group_label>
    <arm_group_label>Portable Oxygen Cylinder</arm_group_label>
    <other_name>Respironics Airsep (rental) AssetNumber 38269</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients diagnosed with stable COPD&#xD;
&#xD;
          -  currently prescribed and using portable oxygen cylinders with a &quot;pulsed&quot; oxygen&#xD;
             delivery for exertion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Co-morbidities such as: other major respiratory conditions, cardiac or other&#xD;
             substantial co-morbidities which significantly limit mobility independent of COPD&#xD;
&#xD;
          -  Baseline step test which demonstrates a reduced effect on the battery device compared&#xD;
             to oxygen cylinders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian J Smith, MBBS, FRACP, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Queen Elizabeth Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital</name>
      <address>
        <city>Woodville Road, Woodville</city>
        <state>South Australia</state>
        <zip>5022</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>April 6, 2017</last_update_submitted>
  <last_update_submitted_qc>April 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Queen Elizabeth Hospital</investigator_affiliation>
    <investigator_full_name>Kristin Carson</investigator_full_name>
    <investigator_title>Research Scientist</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Oxygen cylinder</keyword>
  <keyword>Portable oxygen cylinder</keyword>
  <keyword>Battery powered delivery device</keyword>
  <keyword>mobility</keyword>
  <keyword>dyspnoea</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Cost effectiveness</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be available upon request.</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/NCT01673685
org study id: 2010090
nct id: NCT01673685
lead sponsor: 
has dmc: Yes
Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to
      improve quality of life and other outcomes for patients with chronic obstructive pulmonary
      disease.
Many patients with Chronic Obstructive Pulmonary Disease (COPD) have limited activities of
      daily living (shopping, visiting friends, going for a walk) due to exertional dyspnoea. State
      Government funding provides up to 4 oxygen cylinders to be delivered to patients requiring
      portable oxygen per month. However, the more active and motivated COPD patients often find
      these gratis supplies run out well before the month is up. Recent technology has developed
      battery powered portable oxygen concentrators. The latest models weigh less than a typical
      oxygen cylinder and have the advantage that the battery plug can be plugged into a car
      cigarette lighter outlet, or into the power point of any house. This means that the COPD
      patient has the potential to be far more mobile for far longer periods of time and visit
      friends almost infinitely by recharging the battery pack during the course of their travels.
      The latest battery powered oxygen device weighs 2kgs which is about half that of an oxygen
      cylinder. However, there is an upfront expense to these devices and inevitably a sound
      business case with cost considerations (amortization of the initial purchase price,
      recharging the battery costing the patient's electricity etc) needs consideration. Also,
      before assuming these devices are superior (or at least as good as) oxygen cylinders, because
      they have a pulsed delivery of oxygen technology i.e. the oxygen is delivered in bursts with
      each inspiration that is detected, unlike oxygen cylinders which can run continuously, one
      cannot assume without rigorous evaluation that mobility and quality of life necessarily is
      good or superior with the new devices. Hence, quality of life evaluation with emphasis on
      enjoyed activities by each COPD patient are essential as well as costing issues for the
      funding stakeholder (i.e. hospital site specific funds). Should a sound business case be made
      (i.e. improved quality of life with less costs over a longer period of time), then a sound
      justification can be made to funding bodies that COPD patients are better off and the funding
      body is shouldering less cost by wider usage of these devices following evaluation of this
      project. The design will be a randomised crossover such that COPD patients will spend one
      month on oxygen or battery powered concentrator devices and then switch over to the other
      oxygen delivery. Chronic Respiratory Questionnaire (Quality of Life) will be administered at
      the end of each month.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Portable oxygen concentrators vs oxygen cylinders
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life as measured through Chronic Respiratory Questionnaire
time frame: One month
description: only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain
measure: Patient Preference
time frame: One month
description: Five 7-point Likert Scales, ranging from 1 (none of the time) to 7 (all of the time) on portability ("the equipment was portable enough for my needs"), operation ("I was able to set up and operate the equipment properly"), noise ("Noise from the equipment affected me"), comprehension ("I was able to understand the functions of the equipment, e.g. alarms") and duration ("The oxygen lasted long enough for me to perform my normal activities"). Furthermore, patients were asked to provide comments on use of the POCs and the Cylinders after they completed the respective stage of the trial.
measure: Cost effectiveness of portable oxygen concentrator compared to cylinder
time frame: one month
description: Economic assessment based on treatment cost, readmission data and hospital utilisation
measure: Quality of life as measured through AQoL-8D
time frame: One month
description: Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility Instrument
arm group label: Portable Oxygen Cylinder
arm group type: Placebo Comparator
description: Portable Oxygen Cylinder
arm group label: Portable Oxygen Concentrator
arm group type: Active Comparator
description: Portable Oxygen Concentrator
intervention type: Device
intervention name: Portable Oxygen
arm group label: Portable Oxygen Concentrator
arm group label: Portable Oxygen Cylinder
other name: Respironics Airsep (rental) AssetNumber 38269
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Brian J Smith, MBBS, FRACP, PhD
role: Principal Investigator
affiliation: The Queen Elizabeth Hospital
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The Queen Elizabeth Hospital
investigator full name: Kristin Carson
investigator title: Research Scientist
sharing ipd: Yes
ipd description: IPD will be available upon request.