Exercise in Air Pollution and Lung Health in Asthmatics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2021-05-31

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.

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Detailed Description

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Conditions

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Exercise-induced Bronchoconstriction Air Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rest (Sitting on chair)

Intervention Type OTHER

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

Salbutamol inhalation

Intervention Type DRUG

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

Diesel Exhaust Exposure

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Rest (Sitting on chair)

Intervention Type OTHER

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

Placebo inhalation

Intervention Type DRUG

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

Diesel Exhaust Exposure

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Cycling exercise

Intervention Type 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

Intervention Type DRUG

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

Diesel Exhaust Exposure

Intervention Type OTHER

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

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

Group Type PLACEBO_COMPARATOR

Cycling exercise

Intervention Type 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.

Placebo inhalation

Intervention Type DRUG

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

Diesel Exhaust Exposure

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Rest (Sitting on chair)

Intervention Type OTHER

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

Filtered air

Intervention Type OTHER

Participants will be breathing filtered air

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.

Group Type PLACEBO_COMPARATOR

Rest (Sitting on chair)

Intervention Type OTHER

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

Filtered air

Intervention Type OTHER

Participants will be breathing filtered air

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.

Group Type SHAM_COMPARATOR

Cycling exercise

Intervention Type 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

Intervention Type DRUG

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

Filtered air

Intervention Type OTHER

Participants will be breathing filtered air

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

Group Type PLACEBO_COMPARATOR

Cycling exercise

Intervention Type 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.

Placebo inhalation

Intervention Type DRUG

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

Filtered air

Intervention Type OTHER

Participants will be breathing filtered air

Interventions

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Rest (Sitting on chair)

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

Intervention Type 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 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.

Intervention Type OTHER

Salbutamol inhalation

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

Intervention Type DRUG

Placebo inhalation

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

Intervention Type DRUG

Diesel Exhaust Exposure

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

Intervention Type OTHER

Filtered air

Participants will be breathing filtered air

Intervention Type OTHER

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).

Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes