NCT02255630

Brief Summary

Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Although the majority of these studies do not show an ergogenic effect, the small number of studies with extended exercise bouts (\~60 minutes) do show an advantage. The investigators believe that a controlled yet sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have different effects on these two groups of athletes, the investigators will measure exercise performance in both female and male elite cyclists. The investigators hypothesize that athletes will perform better during a combination steady-state/sprint exercise task following salbutamol administration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

September 16, 2014

Last Update Submit

November 9, 2016

Conditions

Ergogenic Athletic Performance

Keywords

salbutamolexercise-induced bronchoconstrictionanaerobic power

Outcome Measures

Primary Outcomes (1)

  • Peak Power Output

    peak power output of the final 30 seconds of the cycling bout will be assessed.

Study Arms (2)

Salbutamol inhalation

EXPERIMENTAL

Study participants will be exposed to 1600ug salbutamol 30min prior to exercise

Other: Cycling Exercise

Placebo inhalation

EXPERIMENTAL

Study participants will be exposed to 1600ug salbutamol 30min prior to exercise

Other: Cycling Exercise

Interventions

Cycling ExerciseOTHER
Placebo inhalationSalbutamol inhalation

Eligibility Criteria

Age19 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1 for men and women

You may not qualify if:

  • pregnant women
  • any history of uncontrolled respiratory or cardiac disease
  • smokers
  • diabetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Environmental Physiology Laboratory

Vancouver, British Columbia, V6T 1Z1, Canada

Location

Study Officials

  • Michael S Koehle, MD, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2014

First Posted

October 2, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2015

Study Completion

August 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

CA(1)