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
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.