Physiologic Performance Response to Salbutamol

October 29, 2020 updated by: Morten Hostrup, PhD, University of Copenhagen

Individual beta2-adrenergic Performance Response to Salbutamol

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: placebo
Drug: Placebo
administration of placebo
EXPERIMENTAL: salbutamol
salbutamol, 800 microgram from metered dose inhaler
Drug: salbutamol
inhalation of salbutamol

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Measured ½ hour after drug administration
Quadriceps maximal voluntary contraction
Measured ½ hour after drug administration
Sprint fatigue tolerance
Time Frame: Measured ½ hour after drug administration
Fatigue index during maximal cycling
Measured ½ hour after drug administration
Cycling endurance performance
Time Frame: Measured ½ hour after drug administration
4-min time trial on bike ergometer
Measured ½ hour after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 7, 2020

Primary Completion (ANTICIPATED)

November 7, 2021

Study Completion (ANTICIPATED)

November 7, 2021

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (ACTUAL)

November 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAL-POWER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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