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Status unknownNCT03902106Updated Nov 3, 2020

Physiological Response to Salbutamol and Exercise

An interventional study of salbutamol and exercise in Healthy, sponsored by University of Copenhagen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by University of Copenhagen · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    beta2-agonist and exercise

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

    Drug: salbutamol · Other: exercise

  • Sham comparator
    placebo and exercise

    Subjects undergo exercise training with administration of sham placebo

    Other: exercise

Interventions

  • Drugsalbutamol

    subjects ingest salbutamol

  • Otherexercise

    subjects undergo 6 weeks of endurance training (3 times weekly)

06

What researchers measure

Primary outcomes

  1. Body composition

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

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

  2. Maximal oxygen consumption (VO2max)

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

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

Secondary outcomes

  1. Salbutamol urine concentration

    Concentration of salbutamol in urine

    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

Other outcomes

  1. Muscle strength

    Isometric muscle force of the quadriceps

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

07

Study locations

1 of 1 sites recruiting
  • August Krogh Building
    Copenhagen, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03902106
Lead sponsor
University of Copenhagen
Responsible party
Morten Hostrup, PhD (Associate Professor, University of Copenhagen) — Principal investigator
First posted
Apr 3, 2019
Start date
Mar 28, 2019
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Nov 3, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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