BronchoconstrictionPhase 4NCT01903785
Salbutamol, Pharmacogenetics and Breathing Mechanics
A Phase 4 study testing Salbutamol in people with Bronchoconstriction and Inhaled Salbutamol, run by University of British Columbia at 1 site in Canada.
Trial summary
Athletes using asthma medications called β2-agonists win a disproportionately high number of medals at Olympic Games. Due to a large variety in the genes that affect how individuals respond to β2-agonists, the investigators will look at variations in the genetic response to these medications by dividing athletes into… Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchoconstriction, Inhaled Salbutamol, Cycling Performance
- What is being tested?
- Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Aug 2016
- Phase
- Phase 4
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- trained, experienced cyclists
- maximal oxygen consumption of at least 50ml/kg/min or 4l/min for women; and 60ml/kg/min or 5l/min for men
- athletes with and without exercise-induced bronchoconstriction
Who cannot join
- any uncontrolled heart or lung condition
- maximal oxygen consumption of less than 50ml/kg/min or 4L/min for women; and less than 60ml/kg/min or 5L/min for men
- pregnancy
- smoking
Trial locations and contacts
1 site in 1 country.
Canada1 site
Environmental Physiology Laboratory, University of British Columbia
Vancouver, British Columbia, V6T 1Z1
About this study
Official title: The Pharmacogenetic Effects of Inhaled Salbutamol on Breathing Mechanics and Cycling Performance
Athletes using asthma medications called β2-agonists win a disproportionately high number of medals at Olympic Games. Due to a large variety in the genes that affect how individuals respond to β2-agonists, the investigators will look at variations in the genetic response to these medications by dividing athletes into high-responders and low-responders. The investigators will then compare athletic performance after the inhalation of β2-agonists to placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing mechanics. Due to differences in their anatomy females may decrease the energy needed for breathing during high-intensity exercise to a greater extent compared to male athletes after the inhalation of β2-agonists.
- Conditions
- Bronchoconstriction, Inhaled Salbutamol, Cycling Performance
- Being tested
- Salbutamol, Placebo
- Keywords
- exercise-induced bronchoconstriction (EIB), inhaled salbutamol, performance enhancing, cycling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called ventolin
60 minutes prior to the start of a 10km cycling time trial on a bike ergometer, subjects will inhale either 400ug of salbutamol 1600ug of salbutamol or 400ug of placebo in a randomly assigned manner in a single dose.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol | Experimental | 400ug of salbutamol (one single inhalation) will be inhaled 60min prior to the begin of a time trial. Mean power output during the following 10km time trial will be described to 1600ug salbutamol and placebo. Receives: Drug: Salbutamol |
| Placebo | Placebo comparator | 400ug of placebo (one single inhalation) will be inhaled 60min prior to the begin of a time trial. Mean power output during the following 10km time trial will be described to 400ug and 1600ug salbutamol. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of inhaled salbutamol on mean power output during cycling performance in female and male athletes
Athletes perform a two time trials, each on a separate day. The time trials are performed 60min after the inhalation of salbutamol or placebo.
Measured: Mean power output is assessed over the duration of a 10km time trial (start of time trial until completion of time trial) on a bike ergometer.
The effect of inhaled salbutamol on work of breathing (WOB) and expiratory flow limitation (EFL) in female and male athletes
EFL and WOB will be assessed with the help of an esophageal balloon and mouth pressure.
Measured: WOB and EFL will be assessed during an incremental exercise test. Exercise will start at 0 Watts and will then be increased every 2.5min by 30 Watts until maximal exertion.
Secondary outcomes (1)
The effect of inhaled salbutamol on minute ventilation in asthmatic and non-asthmatic trained, female and male cyclists
Measured: Minute ventilation will be assessed during two 10km time trials (one time trial will be started 60min after the inhalation of salbutamol, the second time trial will be started 60min after the inhalation of placebo).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- World Anti-Doping Agency
- Responsible party
- Sponsor
- Investigators
- Michael S Koehle, MD, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903785
- Sponsor's protocol ID
- H09-01154-A009
- Status last verified
- Oct 2016
- First submitted
- 8 Jul 2013
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacogenetic Effects of Inhaled Salbutamol on Breathing Mechanics and Cycling Performance
- ClinicalTrials.gov ID
- NCT01903785
- Acronym / sponsor ID
- H09-01154-A009
- Conditions
- Bronchoconstriction, Inhaled Salbutamol, Cycling Performance
- Keywords
- exercise-induced bronchoconstriction (EIB), inhaled salbutamol, performance enhancing, cycling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- World Anti-Doping Agency
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 19 Jul 2013 (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.
Athletes using asthma medications called β2-agonists win a disproportionately high number of medals at Olympic Games. Due to a large variety in the genes that affect how individuals respond to β2-agonists, the investigators will look at variations in the genetic response to these medications by dividing athletes into high-responders and low-responders. The investigators will then compare athletic performance after the inhalation of β2-agonists to placebo. Furthermore, the investigators will analyze the effect of β2-agonists on breathing mechanics. Due to differences in their anatomy females may decrease the energy needed for breathing during high-intensity exercise to a greater extent compared to male athletes after the inhalation of β2-agonists.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Experimental | Drug: Salbutamol400ug of salbutamol (one single inhalation) will be inhaled 60min prior to the begin of a time trial. Mean power output during the following 10km time trial will be described to 1600ug salbutamol and placebo. |
| Placebo | Placebo comparator | Drug: Placebo400ug of placebo (one single inhalation) will be inhaled 60min prior to the begin of a time trial. Mean power output during the following 10km time trial will be described to 400ug and 1600ug salbutamol. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- trained, experienced cyclists
- maximal oxygen consumption of at least 50ml/kg/min or 4l/min for women; and 60ml/kg/min or 5l/min for men
- athletes with and without exercise-induced bronchoconstriction
Key exclusion criteria (4 listed)
- any uncontrolled heart or lung condition
- maximal oxygen consumption of less than 50ml/kg/min or 4L/min for women; and less than 60ml/kg/min or 5L/min for men
- pregnancy
- smoking
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 |
|---|---|---|
| SalbutamolAlso: ventolin60 minutes prior to the start of a 10km cycling time trial on a bike ergometer, subjects will inhale either 400ug of salbutamol 1600ug of salbutamol or 400ug of placebo in a randomly assigned manner in a single dose. | Drug | Salbutamol |
| Placebo | Drug | Placebo |
Primary outcome
The effect of inhaled salbutamol on mean power output during cycling performance in female and male athletes
Time frame: Mean power output is assessed over the duration of a 10km time trial (start of time trial until completion of time trial) on a bike ergometer.
Athletes perform a two time trials, each on a separate day. The time trials are performed 60min after the inhalation of salbutamol or placebo.
The effect of inhaled salbutamol on work of breathing (WOB) and expiratory flow limitation (EFL) in female and male athletes
Time frame: WOB and EFL will be assessed during an incremental exercise test. Exercise will start at 0 Watts and will then be increased every 2.5min by 30 Watts until maximal exertion.
EFL and WOB will be assessed with the help of an esophageal balloon and mouth pressure.
1 secondary outcome
The effect of inhaled salbutamol on minute ventilation in asthmatic and non-asthmatic trained, female and male cyclists
Time frame: Minute ventilation will be assessed during two 10km time trials (one time trial will be started 60min after the inhalation of salbutamol, the second time trial will be started 60min after the inhalation of placebo).
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 2 Nov 2016.
Related trials for Bronchoconstriction
Not yet recruitingPhase 1
ADO-5030 in Bronchoconstriction Challenge, Phase 1b
Asthma (Diagnosis)
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 Phase 4 study testing Salbutamol in people with Bronchoconstriction and Inhaled Salbutamol, 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 4 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 2 Nov 2016. 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?
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?
The effect of inhaled salbutamol on mean power output during cycling performance in female and male athletes (time frame: Mean power output is assessed over the duration of a 10km time trial (start of time trial until completion of time trial) on a bike ergometer.). 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 2 Nov 2016.