Exercise in Air Pollution and Lung Health in Asthmatics

Study Overview
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Brief Summary
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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.

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

Conditions
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Exercise-induced Bronchoconstriction, Air Pollution

Intervention / Treatment
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* Other: Rest (Sitting on chair)
* Other: Cycling exercise
* Drug: Salbutamol inhalation
* Drug: Placebo inhalation
* Other: Diesel Exhaust Exposure
* Other: Filtered air


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resting in diesel exhaust following salbutamol inhalation<br>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)<br>* Study participants will sit on a chair for 60min. This is to simulate physical resting condition.<br>Drug: Salbutamol inhalation<br>* Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.<br>Other: Diesel Exhaust Exposure<br>* Participants will be exposed to PM2.5 of 300 μg/m3<br>|
| Placebo Comparator: Resting in diesel exhaust following placebo inhalation<br>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)<br>* Study participants will sit on a chair for 60min. This is to simulate physical resting condition.<br>Drug: Placebo inhalation<br>* Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber<br>Other: Diesel Exhaust Exposure<br>* Participants will be exposed to PM2.5 of 300 μg/m3<br>|
| Active Comparator: Cycling in diesel exhaust following salbutamol inhalation<br>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<br>* 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.<br>Drug: Salbutamol inhalation<br>* Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.<br>Other: Diesel Exhaust Exposure<br>* Participants will be exposed to PM2.5 of 300 μg/m3<br>|
| Placebo Comparator: Cycling in diesel exhaust following placebo inhalation<br>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<br>* 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.<br>Drug: Placebo inhalation<br>* Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber<br>Other: Diesel Exhaust Exposure<br>* Participants will be exposed to PM2.5 of 300 μg/m3<br>|
| Sham Comparator: Resting in filtered air following salbutamol inhalation<br>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)<br>* Study participants will sit on a chair for 60min. This is to simulate physical resting condition.<br>Other: Filtered air<br>* Participants will be breathing filtered air<br>|
| Placebo Comparator: Resting in filtered air following placebo inhalation<br>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)<br>* Study participants will sit on a chair for 60min. This is to simulate physical resting condition.<br>Other: Filtered air<br>* Participants will be breathing filtered air<br>|
| Sham Comparator: Cycling in filtered air following salbutamol inhalation<br>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<br>* 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.<br>Drug: Salbutamol inhalation<br>* Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.<br>Other: Filtered air<br>* Participants will be breathing filtered air<br>|
| Placebo Comparator: Cycling in filtered air following placebo inhalation<br>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<br>* 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.<br>Drug: Placebo inhalation<br>* Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber<br>Other: Filtered air<br>* Participants will be breathing filtered air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in rating of perceived exertion for breathing, dyspnea |  | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in work of breathing (WOB) between filtered air and polluted air |  | work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise-induced bronchoconstriction, Air pollution, Exercise, Inhaled beta-2-agonist, Cognitive Function