NCT04616261

Brief Summary

This project aims to examine the trainability of the beta2-adrenergic system with respect to the individual performance response

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
30

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
6 days until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

October 29, 2020

Last Update Submit

November 3, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Sprint performance

    Change in power output during maximal cycling in response to formoterol

    ½ hour after administration of formoterol or placebo

Secondary Outcomes (1)

  • Cycling endurance performance

    ½ hour after administration of formoterol or placebo

Study Arms (2)

SET-HIGH

EXPERIMENTAL

High volume speed endurance training

Behavioral: TrainingDrug: FormoterolDrug: Placebo

SET-LOW

EXPERIMENTAL

Low volume speed endurance training

Behavioral: TrainingDrug: FormoterolDrug: Placebo

Interventions

TrainingBEHAVIORAL

6 weeks of training

SET-HIGHSET-LOW
FormoterolDRUG

inhalation of 54 microg formoterol

SET-HIGHSET-LOW
PlaceboDRUG

inhalation of placebo

SET-HIGHSET-LOW

Eligibility Criteria

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

You may qualify if:

  • to 45 years of age
  • Trained individuals with a maximal oxygen uptake above 55 ml/min/kg
  • Body mass index lower than 26

You may not qualify if:

  • Allergy towards study drug
  • Unacceptable side effects to the study drug
  • Chronic disease deemed by the MD to interfere with the study
  • Smoking
  • Use of prescription medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Formoterol Fumarate

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
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 10, 2020

Primary Completion

November 10, 2022

Study Completion

November 10, 2022

Last Updated

November 4, 2020

Record last verified: 2020-11