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

Phase 4

Completed

• Conditions: Asthma and/or Exercise Induced Bronchoconstriction; Ozone Air Pollution
• Interventions: Drug: Placebo medication; Drug: Salbutamol; Other: Ozone; Other: Filtered Air; Other: Exercise

• Registration Number: NCT05087693
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Study Start: 2021-11-01
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Results First Submitted: 2024-04-04
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Results First Posted: 2025-03-14
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercising in ozone following salbutamol inhalation	Ozone	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.
Exercising in ozone following salbutamol inhalation	Exercise	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.
Exercising in filtered air following salbutamol inhalation	Filtered Air	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.
Exercising in filtered air following salbutamol inhalation	Exercise	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.
Exercising in ozone following placebo inhalation	Placebo medication	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.
Exercising in ozone following placebo inhalation	Ozone	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.
Exercising in ozone following placebo inhalation	Exercise	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.
Exercising in filtered air following placebo inhalation	Placebo medication	Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Exercising in filtered air following placebo inhalation	Filtered Air	Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Exercising in filtered air following placebo inhalation	Exercise	Participants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication.
Exercising in ozone following salbutamol inhalation	Salbutamol	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.
Exercising in filtered air following salbutamol inhalation	Salbutamol	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.

Primary Outcome Measures

Name	Time	Method
Measured Before and 30 Minutes After Exercise in Each 1 Day Condition	Measured before and 30 minutes after exercise in each 1 day condition	Measure of pulmonary function
Change in FVC From Baseline to 30 Minutes After Exercise	Measured before and 30 minutes after exercise in each 1 day condition	Measure of pulmonary function

Trial Locations

Locations (1)

Environmental Physiology Laboratory; 🇨🇦 Vancouver, British Columbia, Canada