Physiologic Performance Response to Salbutamol | NCT04615611

Studies
Physiologic Performance Response to Salbutamol

NCT04615611

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Nov 4, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

salbutamol
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

Oct 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 7, 2020Estimated

Primary Completion Date

Nov 7, 2021Estimated

Completion Date

Nov 7, 2021Estimated

First Submitted Date

Oct 29, 2020

First Submission Date that Met QC Criteria

Oct 29, 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

Oct 29, 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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
salbutamol	Experimental	salbutamol, 800 microgram from metered dose inhaler	Drug: salbutamol
placebo	Placebo Comparator	placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
salbutamol	Drug	inhalation of salbutamol	salbutamol
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sprint performance	Power output during maximal cycling	Measured ½ hour after drug administration

Secondary Outcomes

Measure	Description	Time Frame
Muscle strength	Quadriceps maximal voluntary contraction	Measured ½ hour after drug administration
Sprint fatigue tolerance	Fatigue index during maximal cycling

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

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

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
D000420	Albuterol

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided