AsthmaNCT05105529
Adaptation to Ozone in Individuals With Asthma/Exercise-induced Bronchoconstriction
A study testing Exercise, Ozone and Filtere Air in people with Asthma and Asthma, Exercise-Induced, run by University of British Columbia at 2 sites in Canada.
Trial summary
Researchers found that impairments in the cardiopulmonary system caused by acute exposure to ozone were outweighed by repeated exposures to ozone. The goal of this study is to confirm there will be an adaptation similar to what was previously proved but in individuals with asthma and exercise-induced… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma, Asthma, Exercise-Induced, Exercise Induced Asthma
- What is being tested?
- Exercise, Ozone and Filtere Air
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jan 2021to Feb 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recreationally active individuals
- Diagnosed asthma and/or mild exercise-induced bronchoconstriction: defined by an FEV1 fall equal to or greater than 10% but lower than 25% in the eucapnic hyperventilatory test.
- Able to securely perform a maximal exercise test (responded 'no' to all questions on the PAR-Q+ questionnaire)
- Able to communicate in English
Who cannot join
- Diagnosed with any cardiorespiratory or vascular diseases
- Pregnant or potentially pregnant
- Non-smoking
- Lower limb musculoskeletal injury or lower limb limitation to cycle on a bicycle ergometer
- Recent respiratory symptoms or upper tract infection within 4 weeks
- On vitamin (e.g., C or E) supplementation
Trial locations and contacts
2 sites in 1 country.
Michael Koehle contact
Canada2 sites, 2 recruiting
- Recruiting
Environmental Physiology Laboratory
Vancouver, British Columbia, V6T 1Z1
Michael Koehle, MD, PhD, 604 8229331, michael.koehle@ubc.ca
Michael Koehle, MD, PhD
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Michael Koehle, MD, PhD, (604) 822-9331, michael.koehle@ubc.ca
Michael Koehle, MD, PhD
About this study
Official title: Pulmonary and Vascular Adaptations to a 5-days Exercise Protocol in Ozone in Physically Active Individuals With Asthma and Exercise-induced Bronchoconstriction
Researchers found that impairments in the cardiopulmonary system caused by acute exposure to ozone were outweighed by repeated exposures to ozone. The goal of this study is to confirm there will be an adaptation similar to what was previously proved but in individuals with asthma and exercise-induced bronchoconstriction (EIB). The purpose is to examine adaptive responses in a randomized cross-over trial in which physically active individuals will perform submaximal exercise on five days in ozone and filtered air exposures separated by a washout period.
- Being tested
- Exercise, Ozone, Filtere Air
- Keywords
- Ozone, Air pollution, Asthma, Exercise-induced bronchoconstriction
- Medical subject headings
- Asthma, Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Cycling at 60% of VO2max on a cycle ergometer for 30 minutes
OzoneOther
Breathing 170ppb ozone
Filtere AirOther
Breathing filtered air
| Study group | Role | What they receive |
|---|---|---|
| Ozone (O3) group | Experimental | Participants of the experimental group will perform sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone delivered continuously during each exercise session. Receives: Behavioral: Exercise; Other: Ozone |
| Filtered Air | Sham comparator | Participants of the sham group will also perform sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer similar to intervention. However, only in this group, the ozone generator will not be activated so that just filtered air will be delivered to the participant while performing each exercise session. Receives: Behavioral: Exercise; Other: Filtere Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 from baseline to 10 minutes after exercise
Measurement of pulmonary function: forced exhaled volume in the first second (FEV1) in liters
Measured: Measured at baseline and 10 minutes after each exercise bout
Change in FVC from baseline to 10 minutes after exercise
Measurement of pulmonary function: forced vital capacity (FVC) in liters
Measured: Measured at baseline and 10 minutes after each exercise bout
Change in FEF25-75 from baseline to 10 minutes after exercise
Measurement of pulmonary function: forced expiratory flow at 25-75% of pulmonary volume in liters per second (L/s)
Measured: Measured at baseline and 10 minutes after each exercise bout
Secondary outcomes (2)
Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise
Velocity (in meters per second) at which the blood pressure pulse propagates through set points in the circulatory system
Measured: Measured at baseline and 20 minutes after each exercise bout
Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 5 minutes after exercise
Non-invasive airway inflammation biomarker (in part per billion, ppb)
Measured: Measured at baseline and 5 minutes after each exercise bout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jan 2021
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
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
- Investigators
- Michael Koehle, MD PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105529
- Sponsor's protocol ID
- H21-01183
- Status last verified
- May 2022
- First submitted
- 28 Sep 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary and Vascular Adaptations to a 5-days Exercise Protocol in Ozone in Physically Active Individuals With Asthma and Exercise-induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT05105529
- Acronym / sponsor ID
- H21-01183
- Keywords
- Ozone, Air pollution, Asthma, Exercise-induced bronchoconstriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 3 Nov 2021 (actual)
- 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.
Researchers found that impairments in the cardiopulmonary system caused by acute exposure to ozone were outweighed by repeated exposures to ozone. The goal of this study is to confirm there will be an adaptation similar to what was previously proved but in individuals with asthma and exercise-induced bronchoconstriction (EIB). The purpose is to examine adaptive responses in a randomized cross-over trial in which physically active individuals will perform submaximal exercise on five days in ozone and filtered air exposures separated by a washout period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone (O3) group | Experimental | Behavioral: Exercise, Other: OzoneParticipants of the experimental group will perform sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer while inhaling 170ppb ozone delivered continuously during each exercise session. |
| Filtered Air | Sham comparator | Behavioral: Exercise, Other: Filtere AirParticipants of the sham group will also perform sub-maximal exercise (60% of VO2max for 30 minutes) on a cycle ergometer similar to intervention. However, only in this group, the ozone generator will not be activated so that just filtered air will be delivered to the participant while performing each exercise session. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Recreationally active individuals
- Diagnosed asthma and/or mild exercise-induced bronchoconstriction: defined by an FEV1 fall equal to or greater than 10% but lower than 25% in the eucapnic hyperventilatory test.
- Able to securely perform a maximal exercise test (responded 'no' to all questions on the PAR-Q+ questionnaire)
- Able to communicate in English
Key exclusion criteria (6 listed)
- Diagnosed with any cardiorespiratory or vascular diseases
- Pregnant or potentially pregnant
- Non-smoking
- Lower limb musculoskeletal injury or lower limb limitation to cycle on a bicycle ergometer
- Recent respiratory symptoms or upper tract infection within 4 weeks
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 |
|---|---|---|
| ExerciseCycling at 60% of VO2max on a cycle ergometer for 30 minutes | Behavioural | Filtered Air, Ozone (O3) group |
| OzoneBreathing 170ppb ozone | Other | Ozone (O3) group |
| Filtere AirBreathing filtered air | Other | Filtered Air |
Primary outcome
Change in FEV1 from baseline to 10 minutes after exercise
Time frame: Measured at baseline and 10 minutes after each exercise bout
Measurement of pulmonary function: forced exhaled volume in the first second (FEV1) in liters
Change in FVC from baseline to 10 minutes after exercise
Time frame: Measured at baseline and 10 minutes after each exercise bout
Measurement of pulmonary function: forced vital capacity (FVC) in liters
Change in FEF25-75 from baseline to 10 minutes after exercise
Time frame: Measured at baseline and 10 minutes after each exercise bout
Measurement of pulmonary function: forced expiratory flow at 25-75% of pulmonary volume in liters per second (L/s)
2 secondary outcomes
Change in Pulse Wave Velocity (PWV) from baseline to 20 minutes after exercise
Time frame: Measured at baseline and 20 minutes after each exercise bout
Change in Fraction of exhaled nitric oxide (FeNO) from baseline to 5 minutes after exercise
Time frame: Measured at baseline and 5 minutes after each exercise bout
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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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 Koehle contact
Michael Koehle, MD PhD principal investigator
Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Ozone and Filtere Air in people with Asthma and Asthma, Exercise-Induced, run by University of British Columbia at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patric O Gonçalves, BScPT (6048229331, patricog@alumni.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 from baseline to 10 minutes after exercise (time frame: Measured at baseline and 10 minutes after each exercise bout). The study lists 3 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 2 Jun 2022.