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

NCT05087693 | Completed Phase 4 Results

• 1 other identifier: H21-01080
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma and/or Exercise Induced Bronchoconstriction; Ozone Air Pollution

Keywords

Asthma; Exercise Induced Bronchoconstriction; Salbutamol; Ozone

Outcome Measures

Primary Outcomes (2)

• Measured Before and 30 Minutes After Exercise in Each 1 Day Condition

  Measure of pulmonary function

  Measured before and 30 minutes after exercise in each 1 day condition

• Change in FVC From Baseline to 30 Minutes After Exercise

  Measure of pulmonary function

  Measured before and 30 minutes after exercise in each 1 day condition

Study Arms (4)

Exercising in ozone following salbutamol inhalation

EXPERIMENTAL

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; Other: Ozone; Other: Exercise

Exercising in filtered air following salbutamol inhalation

ACTIVE COMPARATOR

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; Other: Filtered Air; Other: Exercise

Exercising in ozone following placebo inhalation

PLACEBO COMPARATOR

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; Other: Ozone; Other: Exercise

Exercising in filtered air following placebo inhalation

PLACEBO COMPARATOR

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; Other: Filtered Air; Other: Exercise

Interventions

Salbutamol DRUG

Inhaling 200ug of salbutamol

Exercising in filtered air following salbutamol inhalation; Exercising in ozone following salbutamol inhalation

Placebo medication DRUG

Inhaling placebo medication

Exercising in filtered air following placebo inhalation; Exercising in ozone following placebo inhalation

Ozone OTHER

Breathing 170ppb ozone

Exercising in ozone following placebo inhalation; Exercising in ozone following salbutamol inhalation

Filtered Air OTHER

Breathing filtered air

Exercising in filtered air following placebo inhalation; Exercising in filtered air following salbutamol inhalation

Exercise OTHER

Cycling at 60% of VO2max on a cycle ergometer

Exercising in filtered air following placebo inhalation; Exercising in filtered air following salbutamol inhalation; Exercising in ozone following placebo inhalation; Exercising in ozone following salbutamol inhalation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Environmental Physiology Laboratory

Vancouver, British Columbia, V6T 1Z1, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Ozone; Exercise

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Oxygen; Gases; Inorganic Chemicals; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Michael Koehle
• Organization: UNiversity of BRitish COlumbia

michael.koehle@ubc.ca

8229331

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Drug condition (placebo or salbutamol) will be double blinded Air quality condition (ozone or filtered air) will be single blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 21, 2021
• Study Start: November 1, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: March 14, 2025
• Results First Posted: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)