<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/NCT02252302</url>
  </required_header>
  <id_info>
    <org_study_id>H13-01079</org_study_id>
    <nct_id>NCT02252302</nct_id>
  </id_info>
  <brief_title>Exercise in Air Pollution and Lung Health in Asthmatics</brief_title>
  <official_title>The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Academy of Sport and Exercise Medicine (CASEM)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Natural Sciences and Engineering Research Council, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fraser Basin Council</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>
      When exposed to air pollution, the asthma symptoms are aggravated and lung function is&#xD;
      impaired. Due to high breathing rates and volumes, physically active individuals are at&#xD;
      particular risk of lung health impairment due to the high breathing rates and volumes.&#xD;
      Greater doses of air pollutants reach deeper areas in the lungs where they can trigger&#xD;
      asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen&#xD;
      even more, allowing the air pollutants to reach even deeper areas of the lung. With this&#xD;
      study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and&#xD;
      lung health in physically active asthmatics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">May 2021</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in rating of perceived exertion for breathing, dyspnea</measure>
    <time_frame>Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in work of breathing (WOB) between filtered air and polluted air</measure>
    <time_frame>work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in spirometry (FEV1 and FVC) between filtered air and polluted air</measure>
    <time_frame>Spirometry will be assessed at baseline and 45min after the start of the exercise bout.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in cognitive function</measure>
    <time_frame>Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.</time_frame>
    <description>cognitive function will be assessed using the NIH toolbox tests and the brain derived neurotrophic factor (BDNF) blood serum measurements</description>
  </other_outcome>
  <other_outcome>
    <measure>Retinal Imaging</measure>
    <time_frame>The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.</time_frame>
    <description>The blood vessels in the eye will be imaged using a camera.</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Exercise-induced Bronchoconstriction</condition>
  <condition>Air Pollution</condition>
  <arm_group>
    <arm_group_label>Resting in diesel exhaust following salbutamol inhalation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resting in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycling in diesel exhaust following salbutamol inhalation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycling in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resting in filtered air following salbutamol inhalation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resting in filtered air following placebo inhalation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycling in filtered air following salbutamol inhalation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cycling in filtered air following placebo inhalation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Rest (Sitting on chair)</intervention_name>
    <description>Study participants will sit on a chair for 60min. This is to simulate physical resting condition.</description>
    <arm_group_label>Resting in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_label>Resting in diesel exhaust following salbutamol inhalation</arm_group_label>
    <arm_group_label>Resting in filtered air following placebo inhalation</arm_group_label>
    <arm_group_label>Resting in filtered air following salbutamol inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cycling exercise</intervention_name>
    <description>Study participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention.</description>
    <arm_group_label>Cycling in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_label>Cycling in diesel exhaust following salbutamol inhalation</arm_group_label>
    <arm_group_label>Cycling in filtered air following placebo inhalation</arm_group_label>
    <arm_group_label>Cycling in filtered air following salbutamol inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salbutamol inhalation</intervention_name>
    <description>Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.</description>
    <arm_group_label>Cycling in diesel exhaust following salbutamol inhalation</arm_group_label>
    <arm_group_label>Cycling in filtered air following salbutamol inhalation</arm_group_label>
    <arm_group_label>Resting in diesel exhaust following salbutamol inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo inhalation</intervention_name>
    <description>Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber</description>
    <arm_group_label>Cycling in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_label>Cycling in filtered air following placebo inhalation</arm_group_label>
    <arm_group_label>Resting in diesel exhaust following placebo inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diesel Exhaust Exposure</intervention_name>
    <description>Participants will be exposed to PM2.5 of 300 μg/m3</description>
    <arm_group_label>Cycling in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_label>Cycling in diesel exhaust following salbutamol inhalation</arm_group_label>
    <arm_group_label>Resting in diesel exhaust following placebo inhalation</arm_group_label>
    <arm_group_label>Resting in diesel exhaust following salbutamol inhalation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Filtered air</intervention_name>
    <description>Participants will be breathing filtered air</description>
    <arm_group_label>Cycling in filtered air following placebo inhalation</arm_group_label>
    <arm_group_label>Cycling in filtered air following salbutamol inhalation</arm_group_label>
    <arm_group_label>Resting in filtered air following placebo inhalation</arm_group_label>
    <arm_group_label>Resting in filtered air following salbutamol inhalation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  mild-moderate asthmatics with controlled treatment (definition of &quot;mild&quot;: percent fall&#xD;
             index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%;&#xD;
             &quot;moderate&quot;: percent fall index at EVH test on screening day between 15 - 20%).&#xD;
&#xD;
          -  men and non-pregnant women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any history of uncontrolled respiratory or cardiac disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  allergic reactions to lidocaine and salbutamol&#xD;
&#xD;
          -  any recent infections or orthopaedic nasal issues/injuries that may interfere with the&#xD;
             insertion of the catheter needed to assess expiratory flow limitation or work of&#xD;
             breathing&#xD;
&#xD;
          -  claustrophobia in small rooms, comparable to the air pollution chamber used for this&#xD;
             study.&#xD;
&#xD;
          -  English as a second language (ESL) - participants who are not able to understand the&#xD;
             risk that may be associated with the participation in this study due to language&#xD;
             difficulties after following the University of British Clinical Research Ethics Board&#xD;
             Guidance Notes 13.2.1. (ESL participants will be given a consent form in the most&#xD;
             appropriate language or an appropriate translator will be present during the initial&#xD;
             consent process).&#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>September 2021</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">September 30, 2014</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Michael Koehle</investigator_full_name>
    <investigator_title>Principal Investigaor</investigator_title>
  </responsible_party>
  <keyword>Exercise-induced bronchoconstriction</keyword>
  <keyword>Air pollution</keyword>
  <keyword>Exercise</keyword>
  <keyword>Inhaled beta-2-agonist</keyword>
  <keyword>Cognitive Function</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Albuterol</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02252302
org study id: H13-01079
nct id: NCT02252302
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
When exposed to air pollution, the asthma symptoms are aggravated and lung function is
      impaired. Due to high breathing rates and volumes, physically active individuals are at
      particular risk of lung health impairment due to the high breathing rates and volumes.
      Greater doses of air pollutants reach deeper areas in the lungs where they can trigger
      asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen
      even more, allowing the air pollutants to reach even deeper areas of the lung. With this
      study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and
      lung health in physically active asthmatics.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in rating of perceived exertion for breathing, dyspnea
time frame: Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.
measure: Change in work of breathing (WOB) between filtered air and polluted air
time frame: work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout
measure: Change in spirometry (FEV1 and FVC) between filtered air and polluted air
time frame: Spirometry will be assessed at baseline and 45min after the start of the exercise bout.
measure: Change in cognitive function
time frame: Cognitive function will be assessed at baseline (prior to entering the air pollution chamber) and 45 min after the start of the exercise intervention.
description: cognitive function will be assessed using the NIH toolbox tests and the brain derived neurotrophic factor (BDNF) blood serum measurements
measure: Retinal Imaging
time frame: The retina will be imaged at baseline (prior to entering the air pollution chamber) and 20 min after the completion of the exercise intervention.
description: The blood vessels in the eye will be imaged using a camera.
arm group label: Resting in diesel exhaust following salbutamol inhalation
arm group type: Active Comparator
description: Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol.
arm group label: Resting in diesel exhaust following placebo inhalation
arm group type: Placebo Comparator
description: Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo.
arm group label: Cycling in diesel exhaust following salbutamol inhalation
arm group type: Active Comparator
description: Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol.
arm group label: Cycling in diesel exhaust following placebo inhalation
arm group type: Placebo Comparator
description: Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo
arm group label: Resting in filtered air following salbutamol inhalation
arm group type: Sham Comparator
description: Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol.
arm group label: Resting in filtered air following placebo inhalation
arm group type: Placebo Comparator
description: Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo.
arm group label: Cycling in filtered air following salbutamol inhalation
arm group type: Sham Comparator
description: Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.
arm group label: Cycling in filtered air following placebo inhalation
arm group type: Placebo Comparator
description: Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo
intervention type: Other
intervention name: Rest (Sitting on chair)
description: Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
arm group label: Resting in diesel exhaust following placebo inhalation
arm group label: Resting in diesel exhaust following salbutamol inhalation
arm group label: Resting in filtered air following placebo inhalation
arm group label: Resting in filtered air following salbutamol inhalation
intervention type: Other
intervention name: Cycling exercise
description: Study participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention.
arm group label: Cycling in diesel exhaust following placebo inhalation
arm group label: Cycling in diesel exhaust following salbutamol inhalation
arm group label: Cycling in filtered air following placebo inhalation
arm group label: Cycling in filtered air following salbutamol inhalation
intervention type: Drug
intervention name: Salbutamol inhalation
description: Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
arm group label: Cycling in diesel exhaust following salbutamol inhalation
arm group label: Cycling in filtered air following salbutamol inhalation
arm group label: Resting in diesel exhaust following salbutamol inhalation
intervention type: Drug
intervention name: Placebo inhalation
description: Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
arm group label: Cycling in diesel exhaust following placebo inhalation
arm group label: Cycling in filtered air following placebo inhalation
arm group label: Resting in diesel exhaust following placebo inhalation
intervention type: Other
intervention name: Diesel Exhaust Exposure
description: Participants will be exposed to PM2.5 of 300 μg/m3
arm group label: Cycling in diesel exhaust following placebo inhalation
arm group label: Cycling in diesel exhaust following salbutamol inhalation
arm group label: Resting in diesel exhaust following placebo inhalation
arm group label: Resting in diesel exhaust following salbutamol inhalation
intervention type: Other
intervention name: Filtered air
description: Participants will be breathing filtered air
arm group label: Cycling in filtered air following placebo inhalation
arm group label: Cycling in filtered air following salbutamol inhalation
arm group label: Resting in filtered air following placebo inhalation
arm group label: Resting in filtered air following 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: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Michael Koehle
investigator title: Principal Investigaor
mesh term: Albuterol