Physiological Response to Salbutamol and Exercise

October 29, 2020 updated by: Morten Hostrup, PhD, University of Copenhagen
The scope of the study is to investigate the physiological response to salbutamol and exercise. A particular focus is on the metabolic response and amine metabolism.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • August Krogh Building

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy
  • VO2max of >55 ml/min/kg for men and >50 ml/min/kg for women
  • Body mass index (BMI) < 26

Exclusion Criteria:

  • Chronic use of beta2-agonist or allergy towards beta2-agonist
  • Serious adverse effects to beta2-agonist
  • Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
  • Smoking
  • Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
  • Pregnancy (for women)

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: beta2-agonist and exercise
Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2)
Drug: salbutamol
subjects ingest salbutamol
Other: exercise
subjects undergo 6 weeks of endurance training (3 times weekly)
Sham Comparator: placebo and exercise
Subjects undergo exercise training with administration of sham placebo
Other: exercise
subjects undergo 6 weeks of endurance training (3 times weekly)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Change in body composition (measured by dual energy x ray absorptiometry)
Baseline, 2 weeks, 4 weeks and 6 weeks
Maximal oxygen consumption (VO2max)
Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Change in VO2max (measured during bike ergometer cycling to exhaustion)
Baseline, 2 weeks, 4 weeks and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salbutamol urine concentration
Time Frame: Before (baseline) as well as 0-1 hours, 1-2 hours, 2-4 hours, 4-8 hours, and 8-16 hours after administration
Concentration of salbutamol in urine
Before (baseline) as well as 0-1 hours, 1-2 hours, 2-4 hours, 4-8 hours, and 8-16 hours after administration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Isometric muscle force of the quadriceps
Baseline, 2 weeks, 4 weeks and 6 weeks

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 (Actual)

March 28, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 3, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 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

  • SALB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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