<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/NCT01722370</url>
  </required_header>
  <id_info>
    <org_study_id>RG-11-132</org_study_id>
    <nct_id>NCT01722370</nct_id>
  </id_info>
  <brief_title>Ambulatory Oxygen Effects on Muscles in COPD</brief_title>
  <acronym>OM-COPD</acronym>
  <official_title>Can Muscle Dysfunction in COPD be Altered by Oxygenation in Patients With Intermittent Hypoxia on Exertion?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Heart of England NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels,&#xD;
      because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15&#xD;
      hours per day, and has established indications and benefits in COPD. However, the indications&#xD;
      for and benefits from ambulatory oxygen supplementation (oxygen just when walking or&#xD;
      exercising) are less well understood, in part due to heterogeneity of previous study designs,&#xD;
      and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in&#xD;
      COPD, which allows us to ascertain mechanisms of disease by measuring their degree of&#xD;
      systemic inflammation pre and post oxygen supplementation, and measuring changes in gene&#xD;
      expression in muscles by means of microarray profiling. Secondly, our study will utilise&#xD;
      follow up of clinical parameters including home activity monitoring to ascertain medium/long&#xD;
      term benefits of oxygen supplementation in a real life setting. Our hypothesis is that&#xD;
      exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gene expression pattern change between interventions in skeletal muscle biopsy</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Six minute walk test distance</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Home activity level as measured by Actigraph</measure>
    <time_frame>6 and 12 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood gases</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 and 12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety and depression score</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Arterial stiffness</measure>
    <time_frame>12 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Medical air equivalent</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxygen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <arm_group_label>Oxygen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Medical air equivalent</intervention_name>
    <arm_group_label>Medical air equivalent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of COPD&#xD;
&#xD;
          -  desaturation on exertion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  using LTOT&#xD;
&#xD;
          -  immobile for other reason than COPD&#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>Alice M Turner</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart of England NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <state>West Midlands</state>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>December 1, 2014</last_update_submitted>
  <last_update_submitted_qc>December 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Birmingham</investigator_affiliation>
    <investigator_full_name>Alice Turner</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <!-- 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/NCT01722370
org study id: RG-11-132
nct id: NCT01722370
lead sponsor: 
collaborator: 
has dmc: No
Patients with chronic obstructive pulmonary disease (COPD) may develop low oxygen levels,
      because of damage to their lungs. Long term oxygen therapy (LTOT) is given for at least 15
      hours per day, and has established indications and benefits in COPD. However, the indications
      for and benefits from ambulatory oxygen supplementation (oxygen just when walking or
      exercising) are less well understood, in part due to heterogeneity of previous study designs,
      and lack of long term follow up. This is a pilot study of supplementary ambulatory oxygen in
      COPD, which allows us to ascertain mechanisms of disease by measuring their degree of
      systemic inflammation pre and post oxygen supplementation, and measuring changes in gene
      expression in muscles by means of microarray profiling. Secondly, our study will utilise
      follow up of clinical parameters including home activity monitoring to ascertain medium/long
      term benefits of oxygen supplementation in a real life setting. Our hypothesis is that
      exertional hypoxia results in muscle dysfunction and this could be prevented by oxygenation.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Gene expression pattern change between interventions in skeletal muscle biopsy
time frame: 12 weeks
measure: Six minute walk test distance
time frame: 12 weeks
measure: Home activity level as measured by Actigraph
time frame: 6 and 12 weeks
measure: Blood gases
time frame: 12 weeks
measure: Quality of life
time frame: 6 and 12 weeks
measure: Anxiety and depression score
time frame: 12 weeks
measure: Arterial stiffness
time frame: 12 weeks
arm group label: Medical air equivalent
arm group type: Placebo Comparator
description: Oxygen-nitrogen mix equivalent to medical air when inhaled from a cylinder at 2l/min
arm group label: Oxygen
arm group type: Experimental
description: Ambulatory oxygen delivered at 2l/min on any activity performed by the patient, using a blinded cylinder
intervention type: Drug
intervention name: Oxygen
arm group label: Oxygen
intervention type: Drug
intervention name: Medical air equivalent
arm group label: Medical air equivalent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alice M Turner
role: Principal Investigator
affiliation: University of Birmingham
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Birmingham
investigator full name: Alice Turner
investigator title: Dr