Salbutamol, Pharmacogenetics and Breathing Mechanics

NCT ID: NCT01903785

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-08-31

Brief Summary

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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

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Conditions

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Bronchoconstriction Inhaled Salbutamol Cycling Performance

Keywords

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exercise-induced bronchoconstriction (EIB) inhaled salbutamol performance enhancing cycling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Salbutamol

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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ventolin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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World Anti-Doping Agency

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael S Koehle, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Environmental Physiology Laboratory, University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H09-01154-A009

Identifier Type: -

Identifier Source: org_study_id