Salbutamol, Pharmacogenetics and Breathing Mechanics

• ClinicalTrials.gov Identifier: NCT01903785
• Recruitment Status: Completed
• First Posted: July 19, 2013
• Last Update Posted: November 2, 2016
• Sponsor: University of British Columbia
• Collaborator: World Anti-doping Agency
• Information provided by (Responsible Party): University of British Columbia

Tracking Information

• First Submitted Date: July 8, 2013
• First Posted Date: July 19, 2013
• Last Update Posted Date: November 2, 2016
• Study Start Date: May 2013
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 24, 2013)

• 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.

Original Primary Outcome Measures (submitted: July 17, 2013)

• The effect of inhaled salbutamol on mean power output during cycling performance in female 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. ]
  Female 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 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.

• Current Secondary Outcome Measures (submitted: July 24, 2013): 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). ]
• Original Secondary Outcome Measures (submitted: July 17, 2013): The effect of inhaled salbutamol on minute ventilation in asthmatic and non-asthmatic trained, female 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). ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Salbutamol, Pharmacogenetics and Breathing Mechanics
• Official Title: The Pharmacogenetic Effects of Inhaled Salbutamol on Breathing Mechanics and Cycling Performance
• Brief 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science

Condition

• Bronchoconstriction
• Inhaled Salbutamol
• Cycling Performance

Intervention

• Drug: Salbutamol
  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.
  Other Name: ventolin
• Drug: Placebo

Study Arms

• Experimental: Salbutamol
  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.
  Intervention: Drug: Salbutamol
• Placebo Comparator: Placebo
  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.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 31, 2016): 94
• Original Estimated Enrollment (submitted: July 17, 2013): 30
• Actual Study Completion Date: August 2016
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01903785
• Other Study ID Numbers: H09-01154-A009
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of British Columbia
• Original Responsible Party: Same as current
• Current Study Sponsor: University of British Columbia
• Original Study Sponsor: Same as current
• Collaborators: World Anti-doping Agency

Investigators

• Principal Investigator: Michael S Koehle, MD, PhD; University of British Columbia

• PRS Account: University of British Columbia
• Verification Date: October 2016