<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/NCT01702025</url>
  </required_header>
  <id_info>
    <org_study_id>N66001-10-C-2134</org_study_id>
    <nct_id>NCT01702025</nct_id>
  </id_info>
  <brief_title>Rapid Acclimatization to Hypoxia at Altitude</brief_title>
  <official_title>Rapid Acclimatization to Hypoxia at Altitude</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Defense Advanced Research Projects Agency</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Colorado State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In low oxygen environments, such as altitude, some adults may become ill and suffer from&#xD;
      acute mountain sickness. Further, all adults will find that exercising becomes much more&#xD;
      difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of&#xD;
      this investigation is to study the effects of two drugs that may help people adjust to&#xD;
      high-altitude quickly, prevent them from becoming ill and improve their exercise performance.&#xD;
      The drugs are Methazolamide and Aminophylline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).</measure>
    <time_frame>The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia</time_frame>
    <description>After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Physiological Function in Low Oxygen Environment</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.&#xD;
Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aminophylline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.&#xD;
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methazolamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.&#xD;
Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aminophylline+Methazolamide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)&#xD;
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Yellow corn meal in gel capsules</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Yellow corn meal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aminophylline</intervention_name>
    <description>National Drug Code (NDC) 0143-1020-01</description>
    <arm_group_label>Aminophylline</arm_group_label>
    <other_name>Theophylline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methazolamide</intervention_name>
    <description>NDC 0781-1072-01</description>
    <arm_group_label>Methazolamide</arm_group_label>
    <other_name>Neptazane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aminophylline+Methazolamide</intervention_name>
    <description>NDC 0143-1020-01 and NDC 0781-1072-01</description>
    <arm_group_label>Aminophylline+Methazolamide</arm_group_label>
    <other_name>Theophylline + Neptazane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  normotensive (i.e. &lt;140/90 mmHg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  nursing mother&#xD;
&#xD;
          -  current tobacco use or regular use within the previous two years&#xD;
&#xD;
          -  use of prescription medication other than birth control&#xD;
&#xD;
          -  asthma or any other type of lung/respiratory dysfunction&#xD;
&#xD;
          -  resting oxygen saturation &lt;95%&#xD;
&#xD;
          -  unwillingness to abstain from exercise for 48 hours prior to laboratory testing&#xD;
&#xD;
          -  use of anticoagulant therapy or have a known or suspected bleeding disorder&#xD;
&#xD;
          -  identification of contraindication during screening (i.e. positive stress test)&#xD;
&#xD;
          -  any history of mountain sickness (altitude sickness)&#xD;
&#xD;
          -  any history of allergic reaction, hypersensitivity or idiosyncratic reaction to any of&#xD;
             the products administered during the study, including allergy to any sulfa or&#xD;
             sulfonamide derivatives&#xD;
&#xD;
          -  history of clinically significant illness within 4 weeks prior to Day 1&#xD;
&#xD;
          -  Subjects who have made any significant donation (including plasma) or have had a&#xD;
             significant loss of blood within 30 days prior to visit 1&#xD;
&#xD;
          -  receipt of a transfusion or any blood products within 30 days prior to visit 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher Bell, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Colorado State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado State University, Dept. of Health and Exercise Science</name>
      <address>
        <city>Fort Collins</city>
        <state>Colorado</state>
        <zip>80523-1582</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://hes.chhs.colostate.edu/</url>
    <description>Department of Health and Exercise Science, Colorado State University</description>
  </link>
  <link>
    <url>http://clinicaltrials.gov/ct2/show/NCT01587027?term=THE+SAFETY+EVALUATION+OF+AMINOPHYLLINE+AND+METHAZOLAMIDE+WHEN+ADMINISTERED+ORALLY+ALONE+AND+IN+COMBINATION+TO+HEALTHY+VOLUNTEERS&amp;rank=1</url>
    <description>Initial Safety Trial For Treatments Under Investigation In Current Study</description>
  </link>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <results_first_submitted>August 21, 2014</results_first_submitted>
  <results_first_submitted_qc>October 23, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 24, 2014</results_first_posted>
  <last_update_submitted>October 23, 2014</last_update_submitted>
  <last_update_submitted_qc>October 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Colorado State University</investigator_affiliation>
    <investigator_full_name>Christopher Bell</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Hypoxia</keyword>
  <keyword>Altitude</keyword>
  <keyword>Exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminophylline</mesh_term>
    <mesh_term>Methazolamide</mesh_term>
    <mesh_term>Theophylline</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>19 individual participants enrolled in the study. Participants were provided with the opportunity to re-enroll and enter additional arm(s).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia</description>
        </group>
        <group group_id="P2">
          <title>Aminophylline</title>
          <description>Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia</description>
        </group>
        <group group_id="P3">
          <title>Methazolamide</title>
          <description>Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia</description>
        </group>
        <group group_id="P4">
          <title>Aminophylline + Methazolamide</title>
          <description>Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Equipment failure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects could choose to participate in multiple arms of the trial. Trial arms were separated by a 7 day wash out period following the hypoxia visit of the previous arm.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia</description>
        </group>
        <group group_id="B2">
          <title>Aminophylline</title>
          <description>Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia</description>
        </group>
        <group group_id="B3">
          <title>Methazolamide</title>
          <description>Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia</description>
        </group>
        <group group_id="B4">
          <title>Aminophylline + Methazolamide</title>
          <description>Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27" spread="5"/>
                    <measurement group_id="B2" value="26" spread="7"/>
                    <measurement group_id="B3" value="27" spread="6"/>
                    <measurement group_id="B4" value="27" spread="5"/>
                    <measurement group_id="B5" value="27" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.8" spread="2"/>
                    <measurement group_id="B2" value="25.4" spread="2"/>
                    <measurement group_id="B3" value="25.1" spread="2"/>
                    <measurement group_id="B4" value="25.4" spread="2"/>
                    <measurement group_id="B5" value="25.2" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Fat %</title>
          <units>Percentage of body fat</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.2" spread="3"/>
                    <measurement group_id="B2" value="21.4" spread="7"/>
                    <measurement group_id="B3" value="20.6" spread="2"/>
                    <measurement group_id="B4" value="22.4" spread="7"/>
                    <measurement group_id="B5" value="21.1" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fat Mass</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15.4" spread="2"/>
                    <measurement group_id="B2" value="16.5" spread="5"/>
                    <measurement group_id="B3" value="16.0" spread="2"/>
                    <measurement group_id="B4" value="17.4" spread="5"/>
                    <measurement group_id="B5" value="16.3" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fat Free Mass</title>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.3" spread="7"/>
                    <measurement group_id="B2" value="60.8" spread="8"/>
                    <measurement group_id="B3" value="61.9" spread="7"/>
                    <measurement group_id="B4" value="60.9" spread="9"/>
                    <measurement group_id="B5" value="61.2" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>maximal oxygen uptake (VO2max)</title>
          <units>milliliter/kilogram/minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48.7" spread="8"/>
                    <measurement group_id="B2" value="49.4" spread="10"/>
                    <measurement group_id="B3" value="49.8" spread="8"/>
                    <measurement group_id="B4" value="46.5" spread="8"/>
                    <measurement group_id="B5" value="48.6" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).</title>
        <description>After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.</description>
        <time_frame>The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Normoxia Placebo</title>
            <description>Placebo: single dose Normoxia</description>
          </group>
          <group group_id="O2">
            <title>Hypoxia Placebo</title>
            <description>Placebo: single dose hypoxia</description>
          </group>
          <group group_id="O3">
            <title>Normoxia Aminophylline</title>
            <description>Aminophylline:single dose Normoxia</description>
          </group>
          <group group_id="O4">
            <title>Hypoxia Aminophylline</title>
            <description>Aminophylline:single dose hypoxia</description>
          </group>
          <group group_id="O5">
            <title>Normoxia Methazolamide</title>
            <description>Methazolamide single dose Normoxia</description>
          </group>
          <group group_id="O6">
            <title>Hypoxia Methazolamide</title>
            <description>Methazolamide: single dose hypoxia</description>
          </group>
          <group group_id="O7">
            <title>Normoxia Methazolamide/Aminophylline</title>
            <description>Methazolamide combined with Aminophylline: single dose normoxia</description>
          </group>
          <group group_id="O8">
            <title>Hypoxia Methazolamide/Aminophylline</title>
            <description>Methazolamide combined with Aminophylline: single dose hypoxia</description>
          </group>
        </group_list>
        <measure>
          <title>Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).</title>
          <description>After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="0.7"/>
                    <measurement group_id="O2" value="25.2" spread="1.2"/>
                    <measurement group_id="O3" value="22.2" spread="0.5"/>
                    <measurement group_id="O4" value="24.0" spread="0.7"/>
                    <measurement group_id="O5" value="23.0" spread="0.5"/>
                    <measurement group_id="O6" value="24.6" spread="0.5"/>
                    <measurement group_id="O7" value="24.5" spread="0.9"/>
                    <measurement group_id="O8" value="25.9" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia&#xD;
.</description>
        </group>
        <group group_id="E2">
          <title>Aminophylline</title>
          <description>Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia</description>
        </group>
        <group group_id="E3">
          <title>Methazolamide</title>
          <description>Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia</description>
        </group>
        <group group_id="E4">
          <title>Aminophylline + Methazolamide</title>
          <description>Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Face Tingling</sub_title>
                <description>Tingling sensation in the face</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Double vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lightheadedness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vasovagal</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Vasovagal response following needle stick</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoglycemic event</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>cardiac rhythm</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Changes in premature ventricular contraction 24 days post consumption of study drug</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Christopher Bell, Ph.D.</name_or_title>
      <organization>Department of Health and Exercise Science</organization>
      <phone>(970) 491-7522</phone>
      <email>christopher.bell@colostate.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01702025
org study id: N66001-10-C-2134
nct id: NCT01702025
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In low oxygen environments, such as altitude, some adults may become ill and suffer from
      acute mountain sickness. Further, all adults will find that exercising becomes much more
      difficult when compared with exercise at lower altitudes (e.g. sea-level). The purpose of
      this investigation is to study the effects of two drugs that may help people adjust to
      high-altitude quickly, prevent them from becoming ill and improve their exercise performance.
      The drugs are Methazolamide and Aminophylline.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Magnitude of Decrement in Exercise Time Trial Performance in Hypoxia (Low Oxygen) Compared With Normoxia (Normal Oxygen).
time frame: The exercise trial will begin within 5 hours of exposure to either normoxia or hypoxia
description: After exercising on a stationary cycle ergometer for 30 minutes at a resistance of 100 watts, research participants will complete an exercise time trial. The time taken to cycle a distance equivalent to 7.75 miles will be recorded. On a separate day the experiment will be repeated in hypoxia. It is expected that the time taken to cycle a distance equivalent to 7.75 miles will be longer in hypoxia compared to normoxia. One of the goals of this research is to determine if the hypoxia-mediated performance decrement can be decreased with one of our pharmacological interventions.
arm group label: Placebo
arm group type: Placebo Comparator
description: Administer a single dose of placebo (yellow corn meal in a capsule, gelatin ) in Normoxic Conditions.
Following a minimum of 7 days a single dose placebo will be administered (yellow corn meal in a gelatin capsule) in Hypoxic conditions.
arm group label: Aminophylline
arm group type: Active Comparator
description: Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) in Hypoxic conditions.
arm group label: Methazolamide
arm group type: Active Comparator
description: Administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.
Following a minimum of 7 days administer a single dose of 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
arm group label: Aminophylline+Methazolamide
arm group type: Active Comparator
description: Administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Normoxic Conditions.(Aminophylline+Methazolamide)
Following a minimum of 7 days administer a single dose of 400 mg Aminophylline (4-100 mg tablets) + 250 mg Methazolamide (10-25 mg tablets) in Hypoxic conditions.
intervention type: Drug
intervention name: Placebo
description: Yellow corn meal in gel capsules
arm group label: Placebo
other name: Yellow corn meal
intervention type: Drug
intervention name: Aminophylline
description: National Drug Code (NDC) 0143-1020-01
arm group label: Aminophylline
other name: Theophylline
intervention type: Drug
intervention name: Methazolamide
description: NDC 0781-1072-01
arm group label: Methazolamide
other name: Neptazane
intervention type: Drug
intervention name: Aminophylline+Methazolamide
description: NDC 0143-1020-01 and NDC 0781-1072-01
arm group label: Aminophylline+Methazolamide
other name: Theophylline + Neptazane
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Bell, PhD
role: Principal Investigator
affiliation: Colorado State University
facility: 
country: United States
url: http://hes.chhs.colostate.edu/
description: Department of Health and Exercise Science, Colorado State University
url: http://clinicaltrials.gov/ct2/show/NCT01587027?term=THE+SAFETY+EVALUATION+OF+AMINOPHYLLINE+AND+METHAZOLAMIDE+WHEN+ADMINISTERED+ORALLY+ALONE+AND+IN+COMBINATION+TO+HEALTHY+VOLUNTEERS&rank=1
description: Initial Safety Trial For Treatments Under Investigation In Current Study
responsible party type: Principal Investigator
investigator affiliation: Colorado State University
investigator full name: Christopher Bell
investigator title: Associate Professor
mesh term: Hypoxia
mesh term: Aminophylline
mesh term: Methazolamide
mesh term: Theophylline
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 