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Salbutamol, Pharmacogenetics and Breathing Mechanics

Primary Purpose

Bronchoconstriction, Inhaled Salbutamol, Cycling Performance

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Salbutamol
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bronchoconstriction focused on measuring exercise-induced bronchoconstriction (EIB), inhaled salbutamol, performance enhancing, cycling

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Environmental Physiology Laboratory, University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Salbutamol

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

The effect of inhaled salbutamol on minute ventilation in asthmatic and non-asthmatic trained, female and male cyclists

Full Information

First Posted
July 8, 2013
Last Updated
October 31, 2016
Sponsor
University of British Columbia
Collaborators
World Anti-doping Agency
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1. Study Identification

Unique Protocol Identification Number
NCT01903785
Brief Title
Salbutamol, Pharmacogenetics and Breathing Mechanics
Official Title
The Pharmacogenetic Effects of Inhaled Salbutamol on Breathing Mechanics and Cycling Performance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
World Anti-doping Agency

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchoconstriction, Inhaled Salbutamol, Cycling Performance
Keywords
exercise-induced bronchoconstriction (EIB), inhaled salbutamol, performance enhancing, cycling

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Salbutamol
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Salbutamol
Other Intervention Name(s)
ventolin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
The effect of inhaled salbutamol on mean power output during cycling performance in female and male athletes
Description
Athletes perform a two time trials, each on a separate day. The time trials are performed 60min after the inhalation of salbutamol or placebo.
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.
Title
The effect of inhaled salbutamol on work of breathing (WOB) and expiratory flow limitation (EFL) in female and male athletes
Description
EFL and WOB will be assessed with the help of an esophageal balloon and mouth pressure.
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.
Secondary Outcome Measure Information:
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael S Koehle, MD, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Environmental Physiology Laboratory, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z1
Country
Canada

12. IPD Sharing Statement

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Salbutamol, Pharmacogenetics and Breathing Mechanics

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