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NCT Number: NCT02252302

Exercise in Air Pollution and Lung Health in Asthmatics

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.

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Key information

Conditions

Exercise-induced Bronchoconstriction Air Pollution Behavior Motor Activity

Age range

19 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Environmental Physiology Laboratory

Vancouver, British Columbia, V6T 1Z1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rest (Sitting on chair)

Other

Study participants will sit on a chair for 60min. This is to simulate physical resting condition.

cycling exercise

Other

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.

Salbutamol inhalation

Drug

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

Placebo inhalation

Drug

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

Diesel Exhaust Exposure

Other

Participants will be exposed to PM2.5 of 300 μg/m3

Filtered Air

Other

Participants will be breathing filtered air

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Academy of Sport and Exercise Medicine (CASEM)
  • Fraser Basin Council
  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity

Important dates

Study start
2015
Primary completion
2016
Study completion
2021
First posted
Sep 30, 2014
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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