NCT07037511

Brief Summary

β2-Agonists, commonly used to treat asthma, have also been used by athletes to enhance performance, leading to their ban by the International Olympic Committee in 1972. Research has shown non-asthmatics receive no benefit from these drugs at therapeutic dosages; however, many elite athletes still use them, and asthmatic athletes often win more Olympic medals. In some non-asthmatics, β2-agonists may improve breathing limitations during high intensity exercise, which may improve performance. Therefore, we aim to examine if there is a select group of non-asthmatic individuals who experience breathing limitations that may receive benefit from β2-agonists.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
57mo left

Started Oct 2025

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress10%
Oct 2025Dec 2030

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

October 30, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 13, 2026

Status Verified

June 1, 2025

Enrollment Period

4.2 years

First QC Date

June 17, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

Exercise PhysiologyExpiratory Flow LimitationNon-AsthmaticsBeta2-Agonists

Outcome Measures

Primary Outcomes (2)

  • Difference in time to exhaustion following salbutamol inhalation compared to placebo inhalation.

    Exercise duration will be measured during a time to exhaustion cardiopulmonary exercise test on a stationary cycle ergometer or treadmill.

    Up to 2 weeks

  • Sex differences in time to exhaustion following salbutamol inhalation

    Exercise duration will be measured during a time to exhaustion cardiopulmonary exercise test on a stationary cycle ergometer or treadmill. Sexes will be compared within modality.

    Up to 2 weeks

Secondary Outcomes (4)

  • To examine the effects of salbutamol on expiratory flow limitation in endurance athletes

    Up to 2 weeks

  • To explore sex differences in dyspnea following salbutamol inhalation.

    Up to 2 weeks

  • To examine ventilatory responses of male and female endurance athletes to exercise with salbutamol.

    Up to 2 weeks

  • To explore the effects of salbutamol on exercise duration and expiratory flow limitation in both asthmatic and non-asthmatic individuals.

    Up to 2 weeks

Study Arms (2)

Salbutamol inhaler

ACTIVE COMPARATOR

Participants will take four inhalations of salbutamol, with 60 seconds between each inhalation, totaling a therapeutic dose of 400µg of salbutamol prior to performing an incremental cardiopulmonary exercise test.

Drug: Salbutamol

Placebo inhaler

PLACEBO COMPARATOR

Participants will take four inhalations of placebo, with 60 seconds between each inhalation, prior to performing an incremental cardiopulmonary exercise test.

Drug: Placebo

Interventions

Meter-dose inhaler of salbutamol performed using large-volume spacer

Salbutamol inhaler

Meter-dose inhaler of placebo performed using large-volume spacer

Placebo inhaler

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aerobic capacity (V̇O2max) greater than 120% predicted
  • Body mass index (BMI) \> 18 and \< 30 kg/m2
  • Ability to read and understand English
  • Currently training and/or competing in endurance sports (i.e. running or cycling)

You may not qualify if:

  • Smoking history or currently smoking. Currently smoking is defined as regular use of cigarettes or cannabis at any point in the past year. History of smoking is defined as smoking more than 1 pack year for cigarettes or the equivalent in cannabis use measured as puffs per day / 200 (number of puffs in a pack of cigarettes).
  • Use of cannabis within the past 30 days or has a smoking history of at least 1 pack year.
  • Use of vaping devices or e-cigarettes in the past 30 days, or has used them more than 10 times in their lifetime.
  • History or current symptoms of cardiopulmonary disease (excluding controlled asthma)
  • Contraindications to exercise testing defined as anything that would prevent exercise under proper and safe conditions (e.g., a problem with the heart or lungs, muscle)
  • Neuromuscular or musculoskeletal condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Officials

  • Jordan A Guenette, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satvir S Dhillon, MSc

CONTACT

Jordan A Guenette, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

October 30, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

March 13, 2026

Record last verified: 2025-06

Locations