<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/NCT03235297</url>
  </required_header>
  <id_info>
    <org_study_id>DLCO</org_study_id>
    <nct_id>NCT03235297</nct_id>
  </id_info>
  <brief_title>Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide</brief_title>
  <acronym>DLCO</acronym>
  <official_title>Effects of Altitude on Single-Breath Diffusing Capacity for Carbon Monoxide in Normal Subjects and Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to further understand the effects of altitude on the physiology&#xD;
      of gas exchange in the pulmonary microcirculation in normal subjects and in people with&#xD;
      chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity&#xD;
      for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for&#xD;
      altitude corrections in both study populations to be used clinically in pulmonary labs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The DLCOsb is one of the most common and widely tests clinically used across the world in&#xD;
      pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the&#xD;
      pulmonary circulation. This test is used in the differential diagnosis of respiratory related&#xD;
      symptoms, to grade the degree of severity in lung disease, and to objectively monitor the&#xD;
      progression of disease or the response to therapies. Therefore, it is important to have&#xD;
      standard methods of performing and interpreting this test.This is a prospective study,&#xD;
      collecting data from subjects at different simulated altitudes. The study hypothesis is that&#xD;
      increasing altitude will increase the DLCOsb in a predictable manner that will allow for&#xD;
      mathematical corrections to be applied for uniform interpretation in pulmonary labs at&#xD;
      differing altitudes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of altitude on measured diffusing capacity for carbon monoxide</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">23</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <description>Healthy subjects</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with COPD</arm_group_label>
    <description>Subjects with a diagnosis of COPD</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Men and women, ages 20-80, both healthy subjects and those with a diagnosis of COPD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 20- 80 years&#xD;
&#xD;
          -  Subjects must be either healthy or have been diagnosed with COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia (hemoglobin &lt; 10.0 g/dL)&#xD;
&#xD;
          -  Carboxyhemoglobin &gt; 3%&#xD;
&#xD;
          -  Active smoking&#xD;
&#xD;
          -  Heart disease or heart failure&#xD;
&#xD;
          -  Pulmonary hypertension&#xD;
&#xD;
          -  COPD exacerbation&#xD;
&#xD;
          -  Pneumothroax within 6 months&#xD;
&#xD;
          -  Bullous emphysema on chest imaging (Chest X-ray or CT)&#xD;
&#xD;
          -  Supplemental oxygen use&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Alcohol dependence&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Matt Hegewald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Matthew Hegewald</investigator_full_name>
    <investigator_title>Adjunct Associate Professor, University of Utah</investigator_title>
  </responsible_party>
  <keyword>Altitude</keyword>
  <keyword>Diffusing capacity for carbon monoxide</keyword>
  <keyword>COPD</keyword>
  <keyword>Pulmonary function testing</keyword>
  <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/NCT03235297
org study id: DLCO
nct id: NCT03235297
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to further understand the effects of altitude on the physiology
      of gas exchange in the pulmonary microcirculation in normal subjects and in people with
      chronic obstructive pulmonary disease (COPD) measured as the single-breath diffusing capacity
      for carbon monoxide (DLCOsb). The study will determine a mathematical formula to allow for
      altitude corrections in both study populations to be used clinically in pulmonary labs.
The DLCOsb is one of the most common and widely tests clinically used across the world in
      pulmonary function laboratories to assess gas exchange from the lung to hemoglobin in the
      pulmonary circulation. This test is used in the differential diagnosis of respiratory related
      symptoms, to grade the degree of severity in lung disease, and to objectively monitor the
      progression of disease or the response to therapies. Therefore, it is important to have
      standard methods of performing and interpreting this test.This is a prospective study,
      collecting data from subjects at different simulated altitudes. The study hypothesis is that
      increasing altitude will increase the DLCOsb in a predictable manner that will allow for
      mathematical corrections to be applied for uniform interpretation in pulmonary labs at
      differing altitudes.
observational model: Cohort
time perspective: Prospective
measure: Effect of altitude on measured diffusing capacity for carbon monoxide
time frame: 3 weeks
measure: Comparison of a novel inert gas technique for measuring alveolar volume with body plethysmography
time frame: 4 months
arm group label: Healthy subjects
description: Healthy subjects
arm group label: Subjects with COPD
description: Subjects with a diagnosis of COPD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
last name: Matt Hegewald, MD
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Matthew Hegewald
investigator title: Adjunct Associate Professor, University of Utah
sharing ipd: No