NCT06655012

Brief Summary

The purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
8mo left

Started Oct 2024

Longer than P75 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

October 31, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

October 22, 2024

Last Update Submit

April 7, 2025

Conditions

Healthy

Keywords

Beta2-adrenergic stimulationSkeletal muscle hypertrophy

Outcome Measures

Primary Outcomes (1)

  • Power output during sprint testing

    Power output measured in Watts during a sprint on a bike ergometer

    Through study completion, an average on 2 weeks

Secondary Outcomes (1)

  • Power output during time trial

    Through study completion, an average on 2 weeks

Other Outcomes (1)

  • Quadriceps strength

    Through study completion, an average on 2 weeks

Study Arms (2)

Salmeterol

EXPERIMENTAL

Participants are administered salmeterol from an inhaler device

Drug: Salmeterol

Placebo

PLACEBO COMPARATOR

Participants are administered placebo from an inhaler device

Drug: Placebo

Interventions

SalmeterolDRUG

Participants are administered 200 µg salmeterol (8 puffs) from a MDI device

Salmeterol
PlaceboDRUG

Participants are administered placebo (8 puffs) from a MDI device

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40
  • Physically active \>5 hours a week
  • Maximum oxygen uptake classified as high or very high

You may not qualify if:

  • Active smoker currently or within the past 5 years
  • Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
  • Chronic or acute illness deemed by the responsible study physician to affect the test parameters
  • Deviation from the study protocol
  • Lean mass index \>21 kg/m²
  • Pregnancy
  • Smoker
  • Blood donation during the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

Salmeterol Xinafoate

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, 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 22, 2024

First Posted

October 23, 2024

Study Start

October 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations

DK(1)