Exercise-induced BronchoconstrictionNCT02252302
Exercise in Air Pollution and Lung Health in Asthmatics
A study testing Rest (Sitting on chair), Cycling exercise and Salbutamol inhalation in people with Exercise-induced Bronchoconstriction and Air Pollution, run by University of British Columbia at 1 site in Canada.
Trial summary
When exposed to air pollution, the asthma symptoms are aggravated and lung function is impaired. Due to high breathing rates and volumes, physically active individuals are at particular risk of lung health impairment due to the high breathing rates and volumes. Read more about this study
- Who is it for?
- Ages 19 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Bronchoconstriction, Air Pollution
- What is being tested?
- Rest (Sitting on chair), Cycling exercise and Salbutamol inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mild-moderate asthmatics with controlled treatment (definition of "mild": percent fall index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%; "moderate": percent fall index at EVH test on screening day between 15 - 20%).
- men and non-pregnant women
Who cannot join
- any history of uncontrolled respiratory or cardiac disease
- pregnancy
- allergic reactions to lidocaine and salbutamol
- any recent infections or orthopaedic nasal issues/injuries that may interfere with the insertion of the catheter needed to assess expiratory flow limitation or work of breathing
- claustrophobia in small rooms, comparable to the air pollution chamber used for this study.
- English as a second language (ESL) - participants who are not able to understand the risk that may be associated with the participation in this study due to language difficulties after following the University of British Clinical Research Ethics Board Guidance Notes 13.2.1. (ESL participants will be given a consent form in the most appropriate language or an appropriate translator will be present during the initial consent process).
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia, Environmental Physiology Laboratory
Vancouver, British Columbia, V6T 1Z1
About this study
Official title: The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity
When exposed to air pollution, the asthma symptoms are aggravated and lung function is impaired. Due to high breathing rates and volumes, physically active individuals are at particular risk of lung health impairment due to the high breathing rates and volumes. Greater doses of air pollutants reach deeper areas in the lungs where they can trigger asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen even more, allowing the air pollutants to reach even deeper areas of the lung. With this study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and lung health in physically active asthmatics.
- Being tested
- Rest (Sitting on chair), Cycling exercise, Salbutamol inhalation, Placebo inhalation, Diesel Exhaust Exposure
- Keywords
- Exercise-induced bronchoconstriction, Air pollution, Exercise, Inhaled beta-2-agonist, Cognitive Function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rest (Sitting on chair)Other
Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
Cycling exerciseOther
Study participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention.
Salbutamol inhalationDrug
Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
Placebo inhalationDrug
Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
Diesel Exhaust ExposureOther
Participants will be exposed to PM2.5 of 300 μg/m3
Filtered airOther
Participants will be breathing filtered air
| Study group | Role | What they receive |
|---|---|---|
| Resting in diesel exhaust following salbutamol inhalation | Active comparator | Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol. Receives: Other: Rest (Sitting on chair); Drug: Salbutamol inhalation; Other: Diesel Exhaust Exposure |
| Resting in diesel exhaust following placebo inhalation | Placebo comparator | Participants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo. Receives: Other: Rest (Sitting on chair); Drug: Placebo inhalation; Other: Diesel Exhaust Exposure |
| Cycling in diesel exhaust following salbutamol inhalation | Active comparator | Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol. Receives: Other: Cycling exercise; Drug: Salbutamol inhalation; Other: Diesel Exhaust Exposure |
| Cycling in diesel exhaust following placebo inhalation | Placebo comparator | Participants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo Receives: Other: Cycling exercise; Drug: Placebo inhalation; Other: Diesel Exhaust Exposure |
| Resting in filtered air following salbutamol inhalation | Sham comparator | Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol. Receives: Other: Rest (Sitting on chair); Other: Filtered air |
| Resting in filtered air following placebo inhalation | Placebo comparator | Participants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo. Receives: Other: Rest (Sitting on chair); Other: Filtered air |
| Cycling in filtered air following salbutamol inhalation | Sham comparator | Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol. Receives: Other: Cycling exercise; Drug: Salbutamol inhalation; Other: Filtered air |
| Cycling in filtered air following placebo inhalation | Placebo comparator | Participants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo Receives: Other: Cycling exercise; Drug: Placebo inhalation; Other: Filtered air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rating of perceived exertion for breathing, dyspnea
Measured: Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.
Secondary outcomes (1)
Change in work of breathing (WOB) between filtered air and polluted air
Measured: work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Academy of Sport and Exercise Medicine (CASEM), Natural Sciences and Engineering Research Council, Canada, Fraser Basin Council
- Responsible party
- Principal investigator, Michael Koehle, University of British Columbia
- Investigators
- Michael S Koehle, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252302
- Sponsor's protocol ID
- H13-01079
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2014
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inhaled Beta-2-Agonists and Air Pollution on Lung Function and Athletic Capacity
- ClinicalTrials.gov ID
- NCT02252302
- Acronym / sponsor ID
- H13-01079
- Keywords
- Exercise-induced bronchoconstriction, Air pollution, Exercise, Inhaled beta-2-agonist, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Academy of Sport and Exercise Medicine (CASEM), Natural Sciences and Engineering Research Council, Canada, Fraser Basin Council
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When exposed to air pollution, the asthma symptoms are aggravated and lung function is impaired. Due to high breathing rates and volumes, physically active individuals are at particular risk of lung health impairment due to the high breathing rates and volumes. Greater doses of air pollutants reach deeper areas in the lungs where they can trigger asthma-symptoms. When treating these symptoms with inhaled beta-2-agonists the airways widen even more, allowing the air pollutants to reach even deeper areas of the lung. With this study the investigators investigate how inhaled beta-2-agonists affect athletic capacity and lung health in physically active asthmatics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Resting in diesel exhaust following salbutamol inhalation | Active comparator | Other: Rest (Sitting on chair), Drug: Salbutamol inhalation, Other: Diesel Exhaust ExposureParticipants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of 400ug of salbutamol. |
| Resting in diesel exhaust following placebo inhalation | Placebo comparator | Other: Rest (Sitting on chair), Drug: Placebo inhalation, Other: Diesel Exhaust ExposureParticipants will be sitting in an air pollution chamber while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1hour following the inhalation of a placebo. |
| Cycling in diesel exhaust following salbutamol inhalation | Active comparator | Other: Cycling exercise, Drug: Salbutamol inhalation, Other: Diesel Exhaust ExposureParticipants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of 400ug of salbutamol. |
| Cycling in diesel exhaust following placebo inhalation | Placebo comparator | Other: Cycling exercise, Drug: Placebo inhalation, Other: Diesel Exhaust ExposureParticipants will be cycling while being exposed to diesel exhaust (PM2.5 of 300 μg/m3) for a total of 1 hr following the inhalation of a placebo |
| Resting in filtered air following salbutamol inhalation | Sham comparator | Other: Rest (Sitting on chair), Other: Filtered airParticipants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of 400ug of salbutamol. |
| Resting in filtered air following placebo inhalation | Placebo comparator | Other: Rest (Sitting on chair), Other: Filtered airParticipants will be sitting while being exposed to filtered air for a total of 1hour following the inhalation of a placebo. |
| Cycling in filtered air following salbutamol inhalation | Sham comparator | Other: Cycling exercise, Drug: Salbutamol inhalation, Other: Filtered airParticipants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of 400ug of salbutamol. |
| Cycling in filtered air following placebo inhalation | Placebo comparator | Other: Cycling exercise, Drug: Placebo inhalation, Other: Filtered airParticipants will be cycling while being exposed to filtered air for a total of 1 hr following the inhalation of a placebo |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- mild-moderate asthmatics with controlled treatment (definition of "mild": percent fall index at eucapnic voluntary hyperpnea (EVH) test on screening day between 10-15%; "moderate": percent fall index at EVH test on screening day between 15 - 20%).
- men and non-pregnant women
Key exclusion criteria (6 listed)
- any history of uncontrolled respiratory or cardiac disease
- pregnancy
- allergic reactions to lidocaine and salbutamol
- any recent infections or orthopaedic nasal issues/injuries that may interfere with the insertion of the catheter needed to assess expiratory flow limitation or work of breathing
- claustrophobia in small rooms, comparable to the air pollution chamber used for this study.
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 |
|---|---|---|
| Rest (Sitting on chair)Study participants will sit on a chair for 60min. This is to simulate physical resting condition. | Other | Resting in diesel exhaust following placebo inhalation, Resting in diesel exhaust following salbutamol inhalation, Resting in filtered air following placebo inhalation, Resting in filtered air following salbutamol inhalation |
| Cycling exerciseStudy participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention. | Other | Cycling in diesel exhaust following placebo inhalation, Cycling in diesel exhaust following salbutamol inhalation, Cycling in filtered air following placebo inhalation, Cycling in filtered air following salbutamol inhalation |
| Salbutamol inhalationStudy participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber. | Drug | Cycling in diesel exhaust following salbutamol inhalation, Cycling in filtered air following salbutamol inhalation, Resting in diesel exhaust following salbutamol inhalation |
| Placebo inhalationStudy participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber | Drug | Cycling in diesel exhaust following placebo inhalation, Cycling in filtered air following placebo inhalation, Resting in diesel exhaust following placebo inhalation |
| Diesel Exhaust ExposureParticipants will be exposed to PM2.5 of 300 μg/m3 | Other | Cycling in diesel exhaust following placebo inhalation, Cycling in diesel exhaust following salbutamol inhalation, Resting in diesel exhaust following placebo inhalation, Resting in diesel exhaust following salbutamol inhalation |
| Filtered airParticipants will be breathing filtered air | Other | Cycling in filtered air following placebo inhalation, Cycling in filtered air following salbutamol inhalation, Resting in filtered air following placebo inhalation, Resting in filtered air following salbutamol inhalation |
Primary outcome
Change in rating of perceived exertion for breathing, dyspnea
Time frame: Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.
1 secondary outcome
Change in work of breathing (WOB) between filtered air and polluted air
Time frame: work of breathing will be assessed every 2.5min for a time period of 45min during the exercise bout
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
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.
Michael S Koehle, MD, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rest (Sitting on chair), Cycling exercise and Salbutamol inhalation in people with Exercise-induced Bronchoconstriction and 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 2 inclusion and 6 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 30 Sep 2021. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in rating of perceived exertion for breathing, dyspnea (time frame: Difference in perceived dyspnea between salbutamol and placebo exposure as well as polluted air and filtered air. Dyspnea ratings will be collected every 2.5min for a duration of 45min during the exercise test.). 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 30 Sep 2021.