NCT03902106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

March 28, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

2.3 years

First QC Date

March 26, 2019

Last Update Submit

October 29, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Body composition

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

    Baseline, 2 weeks, 4 weeks and 6 weeks

  • Maximal oxygen consumption (VO2max)

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

    Baseline, 2 weeks, 4 weeks and 6 weeks

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

  • Muscle strength

    Baseline, 2 weeks, 4 weeks and 6 weeks

Study Arms (2)

beta2-agonist and exercise

ACTIVE COMPARATOR

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

Drug: salbutamolOther: exercise

placebo and exercise

SHAM COMPARATOR

Subjects undergo exercise training with administration of sham placebo

Other: exercise

Interventions

salbutamolDRUG

subjects ingest salbutamol

beta2-agonist and exercise
exerciseOTHER

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

beta2-agonist and exerciseplacebo and exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, Denmark

RECRUITING

MeSH Terms

Interventions

AlbuterolExercise

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 3, 2019

Study Start

March 28, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)