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

Study Overview
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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.

Official Title
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Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution

Conditions
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Asthma and/or Exercise Induced Bronchoconstriction, Ozone Air Pollution

Intervention / Treatment
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* Drug: Salbutamol
* Drug: Placebo medication
* Other: Ozone
* Other: Filtered Air
* Other: Exercise


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercising in ozone following salbutamol inhalation<br>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. | Drug: Salbutamol<br>* Inhaling 200ug of salbutamol<br>Other: Ozone<br>* Breathing 170ppb ozone<br>Other: Exercise<br>* Cycling at 60% of VO2max on a cycle ergometer<br>|
| Active Comparator: Exercising in filtered air following salbutamol inhalation<br>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. | Drug: Salbutamol<br>* Inhaling 200ug of salbutamol<br>Other: Filtered Air<br>* Breathing filtered air<br>Other: Exercise<br>* Cycling at 60% of VO2max on a cycle ergometer<br>|
| Placebo Comparator: Exercising in ozone following placebo inhalation<br>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. | Drug: Placebo medication<br>* Inhaling placebo medication<br>Other: Ozone<br>* Breathing 170ppb ozone<br>Other: Exercise<br>* Cycling at 60% of VO2max on a cycle ergometer<br>|
| Placebo Comparator: Exercising in filtered air following placebo inhalation<br>Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication. | Drug: Placebo medication<br>* Inhaling placebo medication<br>Other: Filtered Air<br>* Breathing filtered air<br>Other: Exercise<br>* Cycling at 60% of VO2max on a cycle ergometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 30 minutes after exercise | Biomarker for airway inflammation | Measured before and 30 minutes after exercise in each condition | 
| Change in FEV1 from baseline to 30 minutes after exercise | Measure of pulmonary function | Measured before and 30 minutes after exercise in each condition | 
| Change in FVC from baseline to 30 minutes after exercise | Measure of pulmonary function | Measured before and 30 minutes after exercise in each condition | 
| Change in FEF25-75 from baseline to 30 minutes after exercise | Measure of pulmonary function | Measured before and 30 minutes after exercise in each condition | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Exercise Induced Bronchoconstriction, Salbutamol, Ozone