<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/NCT03020212</url>
  </required_header>
  <id_info>
    <org_study_id>COLP</org_study_id>
    <nct_id>NCT03020212</nct_id>
  </id_info>
  <brief_title>Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High Altitude</brief_title>
  <acronym>COPD-LTOT</acronym>
  <official_title>Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Live at High Altitude (2640 Meters Above Sea Level): Evaluation of a Proposal for Adjusting Criteria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Neumologica Colombiana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundación Neumologica Colombiana</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A clinical, prospective, randomized controlled trial to determine the effect of prescribing&#xD;
      oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen&#xD;
      tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on&#xD;
      echocardiogram (which are considered manifestations of chronic hypoxia)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A clinical, prospective, randomized controlled trial to determine the effect of prescribing&#xD;
      oxygen in a group of COPD patients with PaO2 ≥50 and ≤55 mmHg who do not have erythrocytosis&#xD;
      or pulmonary hypertension on echocardiogram (which are considered manifestations of chronic&#xD;
      hypoxia). It will be included 220 patients of the Fundación Neumológica Colombiana living in&#xD;
      Bogotá who accept their participation by signing an informed consent.&#xD;
&#xD;
      The subjects will be randomly assigned to receive or not LTOT and they will be followed for&#xD;
      20 to 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically&#xD;
      evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with&#xD;
      bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE)&#xD;
      and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of&#xD;
      erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of&#xD;
      life, lung function, neurocognitive performance and exercise tolerance by comparing the&#xD;
      groups with and without LTOT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">November 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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Development of pulmonary hypertension</measure>
    <time_frame>3 years</time_frame>
    <description>An echocardiogram will be conducted every ten months to measure the value of pulmonary artery pressure and establish the presence of pulmonary hypertension</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of polycythemia</measure>
    <time_frame>3 years</time_frame>
    <description>A sample of hematocrit and hemoglobine will be perfomed to establish the presence of polycythemia at the begining of the study and every 10 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the pulmonary function</measure>
    <time_frame>3 years</time_frame>
    <description>Spirometry will be conducted to assess the Forced expiratory volume at 1 second and the Forced vital capacity at the begining of the study and every 10 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of exacerbations</measure>
    <time_frame>3 years</time_frame>
    <description>It will report the number of exacerbations that present the patients during the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the quality of life</measure>
    <time_frame>3 years</time_frame>
    <description>It will perform the St. George Respiratory Questionnaire (SGRQ) to assess the quality of life of the patients at the begining of the study and every 10 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of neurocognitive function</measure>
    <time_frame>3 years</time_frame>
    <description>It will make a Mini mental Test to evaluate the neurocognitive performance at the begining of the study and every 10 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of exercise tolerance</measure>
    <time_frame>3 years</time_frame>
    <description>It will conduct a six minute walk test to assess the exercise tolerance at the the begining of the study and every 10 months.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">220</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not oxygen</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention ( no therapy with oxygen)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxygen</intervention_name>
    <description>The subjects will be randomly assigned to receive or not LTOT and they will be followed for 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE) and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of life, lung function, neurocognitive performance and exercise tolerance by comparing the groups with and without LTOT.</description>
    <arm_group_label>Oxygen</arm_group_label>
    <other_name>LTOT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between ≥ 40 years and &lt; 85 years living in Bogotá or in a high -&#xD;
             altitude city (&gt;2.500 - &lt;3.500 m).&#xD;
&#xD;
          -  Diagnosis of COPD defined by FEV1 / FVC &lt;LLN (Lower limit of normal value) and&#xD;
             significant exposure to cigarette ≥ 10 packs / year or woodsmoke ≥ 10 years.&#xD;
&#xD;
          -  Diagnosis of ACO defined by FEV1 / FVC post BD &lt;70%, significant exposure to cigarette&#xD;
             or woodsmoke and asthma diagnosed before 40 years and/or wheezing, cough with&#xD;
             spirometry with a high respond to bronchodilator (FEV1 or FVC ≥ 15% and 400 ml) or&#xD;
             eosinophil &gt;300 cels.&#xD;
&#xD;
          -  PaO2 ≥ 50 and ≤ 55 mmHg or oxygen desaturation during the six-minute walk test (at&#xD;
             least in three of the measurements performed during the exam) or during sleep (SpO2 ≤&#xD;
             85% in ≥ 30% of the total time of sleep)&#xD;
&#xD;
          -  No clinical signs of cor pulmonale&#xD;
&#xD;
          -  Clinically stable COPD defined as no exacerbations in the last three months.&#xD;
&#xD;
          -  Signature of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI ≥40.&#xD;
&#xD;
          -  Paraclinical findings of chronic hypoxemia and pulmonary hypertension:&#xD;
&#xD;
               -  Hematocrit ≥ 55%.&#xD;
&#xD;
               -  Pulmonary hypertension (PH) defined by transthoracic echocardiography systolic&#xD;
                  pulmonary artery pressure &gt; 40 mmHg or indirect signs of PH: Pulmonary artery&#xD;
                  acceleration time &lt;100ms associated with a meso-systolic notch and flattening of&#xD;
                  the septum interventricular in systole.&#xD;
&#xD;
          -  Echocardiographic findings that could lead to pulmonary hypertension.&#xD;
&#xD;
               -  Left ventricular systolic dysfunction defined by an ejection fraction &lt;40%&#xD;
&#xD;
               -  Left ventricular diastolic dysfunction higher than grade I.&#xD;
&#xD;
               -  Valvular disease higher than moderate&#xD;
&#xD;
          -  Use of oxygen &gt; 12 hours a day for more than six months in the last year.&#xD;
&#xD;
          -  Comorbidities not controlled or deemed medically that can contribute to mortality&#xD;
             during the study follow-up.&#xD;
&#xD;
          -  Diagnosis of severe sleep apnea-hypopnea syndrome without treatment&#xD;
&#xD;
          -  Plan of transfer of residence below 2.500 meters.&#xD;
&#xD;
          -  Medical, psychiatric, social and administrative conditions that define high&#xD;
             probability of poor adherence to therapy with oxygen.&#xD;
&#xD;
          -  Active smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos A. Torres-Duque, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación Neumológica Colombiana</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carlos A. Torres-Duque, MD</last_name>
    <phone>( +571) 7428900</phone>
    <phone_ext>5100</phone_ext>
    <email>ctorres@neumologica.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mauricio Gonzalez-García, MD</last_name>
    <phone>(+571) 7428900</phone>
    <phone_ext>5101</phone_ext>
    <email>mgonzalez@neumologica.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fundación Neumológica Colombiana</name>
      <address>
        <city>Bogotá</city>
        <zip>110131</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlos A. Torres-Duque, MD</last_name>
      <phone>( +571) 7428900</phone>
      <phone_ext>5100</phone_ext>
      <email>ctorres@neumologica.org</email>
    </contact>
    <contact_backup>
      <last_name>Mauricio Gonzalez-García, MD</last_name>
      <phone>( +571) 7428900</phone>
      <phone_ext>5101</phone_ext>
      <email>mgonzalez@neumologica.org</email>
    </contact_backup>
    <investigator>
      <last_name>Carlos A. Torres-Duque, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mauricio Gonzalez-García, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carlos E. Aguirre-Franco, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Abraham R. Alí-Munive, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alejandro Casas-Herrera, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
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  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic obstructive pulmonary disease</keyword>
  <keyword>High altitude</keyword>
  <keyword>Oxygen</keyword>
  <keyword>long-term oxygen therapy</keyword>
  <keyword>pulmonary hypertension</keyword>
  <keyword>chronic hypoxemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <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/NCT03020212
org study id: COLP
nct id: NCT03020212
lead sponsor: 
collaborator: 
has dmc: No
A clinical, prospective, randomized controlled trial to determine the effect of prescribing
      oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen
      tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on
      echocardiogram (which are considered manifestations of chronic hypoxia)
A clinical, prospective, randomized controlled trial to determine the effect of prescribing
      oxygen in a group of COPD patients with PaO2 ≥50 and ≤55 mmHg who do not have erythrocytosis
      or pulmonary hypertension on echocardiogram (which are considered manifestations of chronic
      hypoxia). It will be included 220 patients of the Fundación Neumológica Colombiana living in
      Bogotá who accept their participation by signing an informed consent.

      The subjects will be randomly assigned to receive or not LTOT and they will be followed for
      20 to 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically
      evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with
      bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE)
      and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of
      erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of
      life, lung function, neurocognitive performance and exercise tolerance by comparing the
      groups with and without LTOT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Development of pulmonary hypertension
time frame: 3 years
description: An echocardiogram will be conducted every ten months to measure the value of pulmonary artery pressure and establish the presence of pulmonary hypertension
measure: Development of polycythemia
time frame: 3 years
description: A sample of hematocrit and hemoglobine will be perfomed to establish the presence of polycythemia at the begining of the study and every 10 months.
measure: Evaluation of the pulmonary function
time frame: 3 years
description: Spirometry will be conducted to assess the Forced expiratory volume at 1 second and the Forced vital capacity at the begining of the study and every 10 months.
measure: Number of exacerbations
time frame: 3 years
description: It will report the number of exacerbations that present the patients during the study
measure: Evaluation of the quality of life
time frame: 3 years
description: It will perform the St. George Respiratory Questionnaire (SGRQ) to assess the quality of life of the patients at the begining of the study and every 10 months.
measure: Assessment of neurocognitive function
time frame: 3 years
description: It will make a Mini mental Test to evaluate the neurocognitive performance at the begining of the study and every 10 months.
measure: Evaluation of exercise tolerance
time frame: 3 years
description: It will conduct a six minute walk test to assess the exercise tolerance at the the begining of the study and every 10 months.
arm group label: Oxygen
arm group type: Active Comparator
description: Long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD)
arm group label: Not oxygen
arm group type: No Intervention
description: No intervention ( no therapy with oxygen)
intervention type: Drug
intervention name: Oxygen
description: The subjects will be randomly assigned to receive or not LTOT and they will be followed for 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE) and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of life, lung function, neurocognitive performance and exercise tolerance by comparing the groups with and without LTOT.
arm group label: Oxygen
other name: LTOT
criteria: 
gender: All
minimum age: 40 Years
maximum age: 84 Years
healthy volunteers: No
last name: Carlos A. Torres-Duque, MD
role: Principal Investigator
affiliation: Fundación Neumológica Colombiana
last name: Carlos A. Torres-Duque, MD
phone: ( +571) 7428900
phone ext: 5100
email: ctorres@neumologica.org
last name: Mauricio Gonzalez-García, MD
phone: (+571) 7428900
phone ext: 5101
email: mgonzalez@neumologica.org
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Colombia
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responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No