Salmeterol Effect on Exercise Performance | NCT06655012

Studies
Salmeterol Effect on Exercise Performance

NCT06655012

Sponsor

University of Copenhagen

Status

Recruiting

Last Update Posted

Apr 9, 2025Actual

Enrollment

36Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Salmeterol
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2025

Last Update Posted Date

Apr 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Salmeterol	Drug	Participants are administered 200 µg salmeterol (8 puffs) from a MDI device	Salmeterol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Power output during time trial	Mean power output measured in Watts during a time trial on a bike ergometer	Through study completion, an average on 2 weeks

Other Outcomes

Measure	Description	Time Frame
Quadriceps strength	Maksimal torque (Nm) achieved during isometric contraction	Through study completion, an average on 2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria:
Age 18-40
Physically active >5 hours a week
Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
August Krogh Building	Recruiting	Copenhagen		2100	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068299	Salmeterol Xinafoate

Ancestor Terms

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided