Physiological Response to Salbutamol and Exercise

NCT ID: NCT03902106

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

beta2-agonist and exercise

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

Group Type ACTIVE_COMPARATOR

salbutamol

Intervention Type DRUG

subjects ingest salbutamol

exercise

Intervention Type OTHER

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

placebo and exercise

Subjects undergo exercise training with administration of sham placebo

Group Type SHAM_COMPARATOR

exercise

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

salbutamol

subjects ingest salbutamol

Intervention Type DRUG

exercise

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Morten Hostrup, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

August Krogh Building

Copenhagen, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Morten Hostrup, PhD

Role: primary

+4524474785

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SALB

Identifier Type: -

Identifier Source: org_study_id