NCT04615611

Brief Summary

This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable healthy

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

November 7, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2021

Completed
Last Updated

November 4, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 29, 2020

Last Update Submit

October 29, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Sprint performance

    Power output during maximal cycling

    Measured ½ hour after drug administration

Secondary Outcomes (3)

  • Muscle strength

    Measured ½ hour after drug administration

  • Sprint fatigue tolerance

    Measured ½ hour after drug administration

  • Cycling endurance performance

    Measured ½ hour after drug administration

Study Arms (2)

salbutamol

EXPERIMENTAL

salbutamol, 800 microgram from metered dose inhaler

Drug: salbutamol

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

salbutamolDRUG

inhalation of salbutamol

salbutamol
PlaceboDRUG

administration of placebo

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 45 years of age
  • Trained individuals with maximal oxygen uptake above 55 mL/kg/min for men and 50 mL/kg/min for women
  • Body mass index lower than 26

You may not qualify if:

  • Allergy towards study drug
  • Unacceptable side effects of the study drug
  • Chronic disease deemed by the MD to impose a risk or severely confound the study outcomes
  • Current smokers
  • Use of prescription medicine
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Albuterol

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

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
Associate Professor

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 4, 2020

Study Start

November 7, 2020

Primary Completion

November 7, 2021

Study Completion

November 7, 2021

Last Updated

November 4, 2020

Record last verified: 2020-10