Asthma and/or Exercise Induced BronchoconstrictionPhase 4NCT05087693
Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)
A Phase 4 study testing Salbutamol, Ozone and Filtered Air in people with Asthma and/or Exercise Induced Bronchoconstriction and Ozone Air Pollution, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma and/or Exercise Induced Bronchoconstriction, Ozone Air Pollution
- What is being tested?
- Salbutamol, Ozone and Filtered Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2021to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have asthma and/or EIB
- Able to perform maximal exercise
- Able to communicate sufficiently using the English language
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Environmental Physiology Laboratory
Vancouver, British Columbia, V6T 1Z1
About this study
Official title: Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution
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.
- Being tested
- Salbutamol, Placebo medication, Ozone, Filtered Air, Exercise
- Keywords
- Asthma, Exercise Induced Bronchoconstriction, Salbutamol, Ozone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Inhaling 200ug of salbutamol
Placebo medicationDrug
Inhaling placebo medication
OzoneOther
Breathing 170ppb ozone
Filtered AirOther
Breathing filtered air
ExerciseOther
Cycling at 60% of VO2max on a cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo medication; Other: Filtered Air; Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measured Before and 30 Minutes After Exercise in Each 1 Day Condition
Measure of pulmonary function
Measured: 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: Measured before and 30 minutes after exercise in each 1 day condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Nov 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Asthma and/or Exercise Induced BronchoconstrictionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Koehle, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087693
- Sponsor's protocol ID
- H21-01080
- Status last verified
- Feb 2025
- First submitted
- 28 Sep 2021
- Last updated
- 14 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any data shared will not contain any personal identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Salbutamol Use in Asthma and/or Exercise Induced Bronchoconstriction Whilst Exercising in Ozone Air Pollution
- ClinicalTrials.gov ID
- NCT05087693
- Acronym / sponsor ID
- H21-01080
- Keywords
- Asthma, Exercise Induced Bronchoconstriction, Salbutamol, Ozone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Posted 14 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercising in ozone following salbutamol inhalation | Experimental | Drug: Salbutamol, Other: Ozone, Other: ExerciseParticipants 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 | Active comparator | Drug: Salbutamol, Other: Filtered Air, Other: ExerciseParticipants 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 comparator | Drug: Placebo medication, Other: Ozone, Other: ExerciseParticipants 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 comparator | Drug: Placebo medication, Other: Filtered Air, Other: ExerciseParticipants will be doing sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling filtered after inhaling placebo medication. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Have asthma and/or EIB
- Able to perform maximal exercise
- Able to communicate sufficiently using the English language
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalbutamolInhaling 200ug of salbutamol | Drug | Exercising in filtered air following salbutamol inhalation, Exercising in ozone following salbutamol inhalation |
| Placebo medicationInhaling placebo medication | Drug | Exercising in filtered air following placebo inhalation, Exercising in ozone following placebo inhalation |
| OzoneBreathing 170ppb ozone | Other | Exercising in ozone following placebo inhalation, Exercising in ozone following salbutamol inhalation |
| Filtered AirBreathing filtered air | Other | Exercising in filtered air following placebo inhalation, Exercising in filtered air following salbutamol inhalation |
| ExerciseCycling at 60% of VO2max on a cycle ergometer | Other | 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 |
Primary outcome
Measured Before and 30 Minutes After Exercise in Each 1 Day Condition
Time frame: 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
Time frame: Measured before and 30 minutes after exercise in each 1 day condition
Measure of pulmonary function
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Any data shared will not contain any personal identifiers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salbutamol, Ozone and Filtered Air in people with Asthma and/or Exercise Induced Bronchoconstriction and Ozone Air Pollution, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measured Before and 30 Minutes After Exercise in Each 1 Day Condition (time frame: Measured before and 30 minutes after exercise in each 1 day condition). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.