Beta2-adrenergic System and Training | NCT04616261

Studies
Beta2-adrenergic System and Training

NCT04616261

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Nov 4, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Training
Formoterol
Placebo

Countries

Not provided

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2020Estimated

Primary Completion Date

Nov 10, 2022Estimated

Completion Date

Nov 10, 2022Estimated

First Submitted Date

Oct 29, 2020

First Submission Date that Met QC Criteria

Nov 3, 2020

First Posted Date

Nov 4, 2020Actual

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

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SET-HIGH	Experimental	High volume speed endurance training	Behavioral: Training Drug: Formoterol Drug: Placebo
SET-LOW	Experimental	Low volume speed endurance training	Behavioral: Training Drug: Formoterol Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training	Behavioral	6 weeks of training	SET-HIGH SET-LOW

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sprint performance	Change in power output during maximal cycling in response to formoterol	½ hour after administration of formoterol or placebo

Secondary Outcomes

Measure	Description	Time Frame
Cycling endurance performance	Change in 4-min time trial performance in response to formoterol	½ hour after administration of formoterol or placebo

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068759	Formoterol Fumarate

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided