Physiological Response to Salbutamol and Exercise

Not Applicable

• Conditions: Healthy
• Interventions: Other: exercise; Drug: salbutamol

• Registration Number: NCT03902106
• Lead Sponsor: University of Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-26
• Study Start: 2019-03-28
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-03
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo and exercise	exercise	Subjects undergo exercise training with administration of sham placebo
beta2-agonist and exercise	exercise	Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2)
beta2-agonist and exercise	salbutamol	Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Concentration of salbutamol in urine

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark