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Clinical Trials/NCT03902106
NCT03902106UnknownNot Applicable

Physiological Response to Salbutamol and Exercise

University of Copenhagen1 site in 1 country40 target enrollmentStarted: March 28, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
40
Locations
1
Primary Endpoint
Maximal oxygen consumption (VO2max)

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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
  • Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
  • Pregnancy (for women)

Arms & Interventions

beta2-agonist and exercise

Active Comparator

Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2)

Intervention: salbutamol (Drug)

beta2-agonist and exercise

Active Comparator

Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2)

Intervention: exercise (Other)

placebo and exercise

Sham Comparator

Subjects undergo exercise training with administration of sham placebo

Intervention: exercise (Other)

Outcomes

Primary Outcomes

Maximal oxygen consumption (VO2max)

Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks

Change in VO2max (measured during bike ergometer cycling to exhaustion)

Body composition

Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks

Change in body composition (measured by dual energy x ray absorptiometry)

Secondary Outcomes

  • Salbutamol urine concentration(Before (baseline) as well as 0-1 hours, 1-2 hours, 2-4 hours, 4-8 hours, and 8-16 hours after administration)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Morten Hostrup, PhD

Associate Professor

University of Copenhagen

Study Sites (1)

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