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Exercise in Air Pollution and Lung Health in Asthmatics

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ClinicalTrials.gov Identifier: NCT02252302
Recruitment Status : Unknown
Verified October 2016 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2014
Last Update Posted : November 1, 2016
Sponsor:
Collaborators:
Canadian Academy of Sport and Exercise Medicine (CASEM)
Natural Sciences and Engineering Research Council, Canada
Fraser Basin Council
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Exercise-induced Bronchoconstriction Air Pollution Other: Rest (Sitting on chair) Other: Cycling exercise Drug: Salbutamol inhalation Drug: Placebo inhalation Other: Diesel Exhaust Exposure Other: Filtered air Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity
Study Start Date : May 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Resting in diesel exhaust following salbutamol inhalation
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.
Other: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.

Drug: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.

Other: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3

Placebo Comparator: Resting in diesel exhaust following placebo inhalation
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.
Other: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.

Drug: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber

Other: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3

Active Comparator: Cycling in diesel exhaust following salbutamol inhalation
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.
Other: Cycling exercise
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 55% 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.

Drug: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.

Other: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3

Placebo Comparator: Cycling in diesel exhaust following placebo inhalation
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
Other: Cycling exercise
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 55% 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.

Drug: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber

Other: Diesel Exhaust Exposure
Participants will be exposed to PM2.5 of 300 μg/m3

Sham Comparator: Resting in filtered air following salbutamol inhalation
Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol.
Other: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.

Other: Filtered air
Participants will be breathing filtered air

Placebo Comparator: Resting in filtered air following placebo inhalation
Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo.
Other: Rest (Sitting on chair)
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.

Other: Filtered air
Participants will be breathing filtered air

Sham Comparator: Cycling in filtered air following salbutamol inhalation
Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol.
Other: Cycling exercise
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 55% 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.

Drug: Salbutamol inhalation
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.

Other: Filtered air
Participants will be breathing filtered air

Placebo Comparator: Cycling in filtered air following placebo inhalation
Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo
Other: Cycling exercise
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 55% 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.

Drug: Placebo inhalation
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber

Other: Filtered air
Participants will be breathing filtered air




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. 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. ]
  2. 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. ]
    cognitive function will be assessed using the NIH toolbox tests and the brain derived neurotrophic factor (BDNF) blood serum measurements

  3. 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. ]
    The blood vessels in the eye will be imaged using a camera.



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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mild-moderate asthmatics with controlled treatment (definition of "mild": percent fall index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%; "moderate": percent fall index at EVH test on screening day between 15 - 20%).
  • men and non-pregnant women

Exclusion Criteria:

  • any history of uncontrolled respiratory or cardiac disease
  • pregnancy
  • allergic reactions to lidocaine and salbutamol
  • any recent infections or orthopaedic nasal issues/injuries that may interfere with the insertion of the catheter needed to assess expiratory flow limitation or work of breathing
  • claustrophobia in small rooms, comparable to the air pollution chamber used for this study.
  • English as a second language (ESL) - participants who are not able to understand the risk that may be associated with the participation in this study due to language difficulties after following the University of British Clinical Research Ethics Board Guidance Notes 13.2.1. (ESL participants will be given a consent form in the most appropriate language or an appropriate translator will be present during the initial consent process).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02252302


Locations
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Canada, British Columbia
University of British Columbia, Environmental Physiology Laboratory
Vancouver, British Columbia, Canada, V6T 1Z1
Sponsors and Collaborators
University of British Columbia
Canadian Academy of Sport and Exercise Medicine (CASEM)
Natural Sciences and Engineering Research Council, Canada
Fraser Basin Council
Investigators
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Principal Investigator: Michael S Koehle, MD, PhD University of British Columbia

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02252302     History of Changes
Other Study ID Numbers: H13-01079
First Posted: September 30, 2014    Key Record Dates
Last Update Posted: November 1, 2016
Last Verified: October 2016
Keywords provided by University of British Columbia:
Exercise-induced bronchoconstriction
Air pollution
Exercise
Inhaled beta-2-agonist
Cognitive Function
Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action