Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-08-31

Brief Summary

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Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.

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Detailed Description

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Conditions

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Asthma and/or Exercise Induced Bronchoconstriction Ozone Air Pollution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded

Study Groups

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Exercising in ozone following salbutamol inhalation

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling 200ug of salbutamol.

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

Inhaling 200ug of salbutamol

Ozone

Intervention Type OTHER

Breathing 170ppb ozone

Exercise

Intervention Type OTHER

Cycling at 60% of VO2max on a cycle ergometer

Exercising in filtered air following salbutamol inhalation

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered air after inhaling 200ug of salbutamol.

Group Type ACTIVE_COMPARATOR

Salbutamol

Intervention Type DRUG

Inhaling 200ug of salbutamol

Filtered Air

Intervention Type OTHER

Breathing filtered air

Exercise

Intervention Type OTHER

Cycling at 60% of VO2max on a cycle ergometer

Exercising in ozone following placebo inhalation

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone after inhaling placebo medication.

Group Type PLACEBO_COMPARATOR

Placebo medication

Intervention Type DRUG

Inhaling placebo medication

Ozone

Intervention Type OTHER

Breathing 170ppb ozone

Exercise

Intervention Type OTHER

Cycling at 60% of VO2max on a cycle ergometer

Exercising in filtered air following placebo inhalation

Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.

Group Type PLACEBO_COMPARATOR

Placebo medication

Intervention Type DRUG

Inhaling placebo medication

Filtered Air

Intervention Type OTHER

Breathing filtered air

Exercise

Intervention Type OTHER

Cycling at 60% of VO2max on a cycle ergometer

Interventions

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Salbutamol

Inhaling 200ug of salbutamol

Intervention Type DRUG

Placebo medication

Inhaling placebo medication

Intervention Type DRUG

Ozone

Breathing 170ppb ozone

Intervention Type OTHER

Filtered Air

Breathing filtered air

Intervention Type OTHER

Exercise

Cycling at 60% of VO2max on a cycle ergometer

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Have asthma and/or EIB
* Able to perform maximal exercise
* Able to communicate sufficiently using the English language

Exclusion Criteria

* Allergic to salbutamol (also known as Ventolin)
* Pregnant or potentially pregnant
* Have a history of smoking
* Had an upper respiratory tract infection within the last 4 weeks
* Have a chronic respiratory disease other than asthma or EIB

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No