<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/NCT01691079</url>
  </required_header>
  <id_info>
    <org_study_id>12-09621</org_study_id>
    <nct_id>NCT01691079</nct_id>
  </id_info>
  <brief_title>Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes</brief_title>
  <acronym>STAMINA</acronym>
  <official_title>Effectiveness of Ipratropium Bromide in Preventing Exercise-induced Bronchoconstriction in Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a double-blind placebo-controlled study in which we plan to study 40 competitive&#xD;
      endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2&#xD;
      exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes&#xD;
      will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the&#xD;
      athletes' airway response to the exercise challenge with and without the active drug.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Exercise-induced asthma (EIA) is common and often unrecognized among endurance athletes. The&#xD;
      mechanisms of asthma appear to be different between athletes and non-athletes, in that the&#xD;
      occurrence of asthma is higher among endurance athletes and seems to be promoted by training.&#xD;
      This suggests that factors inherent to athleticism, such as the parasympathetic nervous&#xD;
      system, which has been shown to change with endurance training and is known to lead to&#xD;
      narrowing of the airways, may be involved with the development of asthma in athletes.&#xD;
      Although asthma mechanisms and treatments have been extensively studied in classic&#xD;
      asthmatics, there is very limited data in athletes.&#xD;
&#xD;
      This will be a double-blind placebo-controlled study in which we plan to study 40 competitive&#xD;
      endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2&#xD;
      exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes&#xD;
      will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the&#xD;
      athletes' airway response to the exercise challenge with and without the active drug.&#xD;
&#xD;
      If ipratropium bromide proves to prevent EIA in athletes, this drug may be appropriate and&#xD;
      effective to target EIA in this population. The results of this study may lead to improved&#xD;
      clinical management of athletes with asthma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Spirometry and Specific Airway Conductance Measured by Body Plethysmography Before and After Exercise Challenge After Randomized Administration of Either Inhaled Ipratropium Bromide or Inhaled Placebo</measure>
    <time_frame>The outcome measures will be assessed over an expected average of 6 months.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific IgE Measurements</measure>
    <time_frame>The outcome measures will be assessed over an expected average of 6 months.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Bronchospasm, Exercise-Induced</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo 2 puffs prior to exercise challenge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ipratropium bromide</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ipratropium bromide HFA 2 puffs prior to exercise challenge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ipratropium bromide</intervention_name>
    <description>Inhaled ipratropium bromide administered before exercise.</description>
    <arm_group_label>ipratropium bromide</arm_group_label>
    <other_name>atrovent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Inhaled placebo administered before exercise.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Athletes &gt; 13 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiac complaints (chest pain, shortness of breath, palpitations, dyspnea&#xD;
             on exertion).&#xD;
&#xD;
          -  History of cardiac disease or taking cardioactive medications.&#xD;
&#xD;
          -  History of smoking.&#xD;
&#xD;
          -  History of glaucoma.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mona Luke-Zeitoun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Clinical Professor (Volunteer)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>May 20, 2020</results_first_submitted>
  <results_first_submitted_qc>May 20, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 5, 2020</results_first_posted>
  <last_update_submitted>May 20, 2020</last_update_submitted>
  <last_update_submitted_qc>May 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchial Spasm</mesh_term>
    <mesh_term>Asthma, Exercise-Induced</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bromides</mesh_term>
    <mesh_term>Ipratropium</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>placebo 2 puffs prior to exercise challenge&#xD;
Placebo: Inhaled placebo administered before exercise.</description>
        </group>
        <group group_id="P2">
          <title>Ipratropium Bromide</title>
          <description>ipratropium bromide HFA 2 puffs prior to exercise challenge&#xD;
ipratropium bromide: Inhaled ipratropium bromide administered before exercise.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>placebo 2 puffs prior to exercise challenge&#xD;
Placebo: Inhaled placebo administered before exercise.</description>
        </group>
        <group group_id="B2">
          <title>Ipratropium Bromide</title>
          <description>ipratropium bromide HFA 2 puffs prior to exercise challenge&#xD;
ipratropium bromide: Inhaled ipratropium bromide administered before exercise.</description>
        </group>
        <group group_id="B3">
          <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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Spirometry and Specific Airway Conductance Measured by Body Plethysmography Before and After Exercise Challenge After Randomized Administration of Either Inhaled Ipratropium Bromide or Inhaled Placebo</title>
        <time_frame>The outcome measures will be assessed over an expected average of 6 months.</time_frame>
        <population>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo 2 puffs prior to exercise challenge&#xD;
Placebo: Inhaled placebo administered before exercise.</description>
          </group>
          <group group_id="O2">
            <title>Ipratropium Bromide</title>
            <description>ipratropium bromide HFA 2 puffs prior to exercise challenge&#xD;
ipratropium bromide: Inhaled ipratropium bromide administered before exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Spirometry and Specific Airway Conductance Measured by Body Plethysmography Before and After Exercise Challenge After Randomized Administration of Either Inhaled Ipratropium Bromide or Inhaled Placebo</title>
          <population>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Specific IgE Measurements</title>
        <time_frame>The outcome measures will be assessed over an expected average of 6 months.</time_frame>
        <population>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>placebo 2 puffs prior to exercise challenge&#xD;
Placebo: Inhaled placebo administered before exercise.</description>
          </group>
          <group group_id="O2">
            <title>Ipratropium Bromide</title>
            <description>ipratropium bromide HFA 2 puffs prior to exercise challenge&#xD;
ipratropium bromide: Inhaled ipratropium bromide administered before exercise.</description>
          </group>
        </group_list>
        <measure>
          <title>Specific IgE Measurements</title>
          <population>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>PI left institution and sincere efforts were made to contact the PI, but were unsuccessful. No data are available to report.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>placebo 2 puffs prior to exercise challenge&#xD;
Placebo: Inhaled placebo administered before exercise.</description>
        </group>
        <group group_id="E2">
          <title>Ipratropium Bromide</title>
          <description>ipratropium bromide HFA 2 puffs prior to exercise challenge&#xD;
ipratropium bromide: Inhaled ipratropium bromide administered before exercise.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Mona Luke-Zeitoun, MD</name_or_title>
      <organization>University of California, San Francisco</organization>
      <email>lukezeitounm@peds.ucsf.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/NCT01691079
org study id: 12-09621
nct id: NCT01691079
lead sponsor: 
has dmc: No
This will be a double-blind placebo-controlled study in which we plan to study 40 competitive
      endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2
      exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes
      will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the
      athletes' airway response to the exercise challenge with and without the active drug.
Exercise-induced asthma (EIA) is common and often unrecognized among endurance athletes. The
      mechanisms of asthma appear to be different between athletes and non-athletes, in that the
      occurrence of asthma is higher among endurance athletes and seems to be promoted by training.
      This suggests that factors inherent to athleticism, such as the parasympathetic nervous
      system, which has been shown to change with endurance training and is known to lead to
      narrowing of the airways, may be involved with the development of asthma in athletes.
      Although asthma mechanisms and treatments have been extensively studied in classic
      asthmatics, there is very limited data in athletes.

      This will be a double-blind placebo-controlled study in which we plan to study 40 competitive
      endurance athletes. We will conduct an exercise test to evaluate maximal oxygen uptake and 2
      exercise challenge tests to provoke EIA. Prior to the exercise challenge tests the athletes
      will randomly receive inhaled placebo or inhaled ipratropium bromide. We will compare the
      athletes' airway response to the exercise challenge with and without the active drug.

      If ipratropium bromide proves to prevent EIA in athletes, this drug may be appropriate and
      effective to target EIA in this population. The results of this study may lead to improved
      clinical management of athletes with asthma.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Spirometry and Specific Airway Conductance Measured by Body Plethysmography Before and After Exercise Challenge After Randomized Administration of Either Inhaled Ipratropium Bromide or Inhaled Placebo
time frame: The outcome measures will be assessed over an expected average of 6 months.
measure: Specific IgE Measurements
time frame: The outcome measures will be assessed over an expected average of 6 months.
arm group label: placebo
arm group type: Placebo Comparator
description: placebo 2 puffs prior to exercise challenge
arm group label: ipratropium bromide
arm group type: Active Comparator
description: ipratropium bromide HFA 2 puffs prior to exercise challenge
intervention type: Drug
intervention name: ipratropium bromide
description: Inhaled ipratropium bromide administered before exercise.
arm group label: ipratropium bromide
other name: atrovent
intervention type: Drug
intervention name: Placebo
description: Inhaled placebo administered before exercise.
arm group label: placebo
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mona Luke-Zeitoun
role: Principal Investigator
affiliation: Assistant Clinical Professor (Volunteer)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bronchial Spasm
mesh term: Asthma, Exercise-Induced
mesh term: Bromides
mesh term: Ipratropium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 