<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/NCT02255630</url>
  </required_header>
  <id_info>
    <org_study_id>H14-02788</org_study_id>
    <nct_id>NCT02255630</nct_id>
  </id_info>
  <brief_title>Anaerobic Power and Salbutamol</brief_title>
  <official_title>The Effects of High-dose Salbutamol on Anaerobic Cycling Power</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Natural Sciences and Engineering Research Council, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of&#xD;
      medals. However, most previous research has shown that β2 agonists do not improve exercise&#xD;
      performance in either asthmatic or non-asthmatic athletes. Although the majority of these&#xD;
      studies do not show an ergogenic effect, the small number of studies with extended exercise&#xD;
      bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet&#xD;
      sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have&#xD;
      different effects on these two groups of athletes, the investigators will measure exercise&#xD;
      performance in both female and male elite cyclists. The investigators hypothesize that&#xD;
      athletes will perform better during a combination steady-state/sprint exercise task following&#xD;
      salbutamol administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Power Output</measure>
    <time_frame>peak power output of the final 30 seconds of the cycling bout will be assessed.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Ergogenic Athletic Performance</condition>
  <arm_group>
    <arm_group_label>Salbutamol inhalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will be exposed to 1600ug salbutamol 30min prior to exercise</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo inhalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants will be exposed to 1600ug salbutamol 30min prior to exercise</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cycling Exercise</intervention_name>
    <arm_group_label>Placebo inhalation</arm_group_label>
    <arm_group_label>Salbutamol inhalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1&#xD;
             for men and women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  any history of uncontrolled respiratory or cardiac disease&#xD;
&#xD;
          -  smokers&#xD;
&#xD;
          -  diabetics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael S Koehle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of British Columbia, Environmental Physiology Laboratory</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6T 1Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>November 9, 2016</last_update_submitted>
  <last_update_submitted_qc>November 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>salbutamol</keyword>
  <keyword>exercise-induced bronchoconstriction</keyword>
  <keyword>anaerobic power</keyword>
  <!-- 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/NCT02255630
org study id: H14-02788
nct id: NCT02255630
lead sponsor: 
collaborator: 
has dmc: No
Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of
      medals. However, most previous research has shown that β2 agonists do not improve exercise
      performance in either asthmatic or non-asthmatic athletes. Although the majority of these
      studies do not show an ergogenic effect, the small number of studies with extended exercise
      bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet
      sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have
      different effects on these two groups of athletes, the investigators will measure exercise
      performance in both female and male elite cyclists. The investigators hypothesize that
      athletes will perform better during a combination steady-state/sprint exercise task following
      salbutamol administration.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Peak Power Output
time frame: peak power output of the final 30 seconds of the cycling bout will be assessed.
arm group label: Salbutamol inhalation
arm group type: Experimental
description: Study participants will be exposed to 1600ug salbutamol 30min prior to exercise
arm group label: Placebo inhalation
arm group type: Experimental
description: Study participants will be exposed to 1600ug salbutamol 30min prior to exercise
intervention type: Other
intervention name: Cycling Exercise
arm group label: Placebo inhalation
arm group label: Salbutamol inhalation
criteria: 
gender: All
minimum age: 19 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael S Koehle, MD, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
country: Canada
responsible party type: Sponsor