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Physiological Response to Salbutamol and Exercise

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ClinicalTrials.gov Identifier: NCT03902106
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Morten Hostrup, PhD, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: salbutamol Other: exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Physiological Response to Salbutamol and Exercise
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


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)




Primary Outcome Measures :
  1. Body composition [ Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks ]
    Change in body composition (measured by dual energy x ray absorptiometry)

  2. Maximal oxygen consumption (VO2max) [ Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks ]
    Change in VO2max (measured during bike ergometer cycling to exhaustion)


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902106


Locations
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Denmark
August Krogh Building Recruiting
Copenhagen, Denmark
Contact: Morten Hostrup, PhD    +4524474785    mhostrup@nexs.ku.dk   
Sponsors and Collaborators
University of Copenhagen

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Responsible Party: Morten Hostrup, PhD, Associate Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03902106     History of Changes
Other Study ID Numbers: SALB
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action