HealthyNCT03902106
Physiological Response to Salbutamol and Exercise
A study testing salbutamol and exercise in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- salbutamol and exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Mar 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- VO2max of >55 ml/min/kg for men and >50 ml/min/kg for women
- Body mass index (BMI) < 26
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen
Morten Hostrup, PhD, +4524474785, mhostrup@nexs.ku.dk
About this study
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.
- Conditions
- Healthy
- Being tested
- salbutamol, exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamolDrug
subjects ingest salbutamol
exerciseOther
subjects undergo 6 weeks of endurance training (3 times weekly)
| Study group | Role | What they receive |
|---|---|---|
| beta2-agonist and exercise | Active comparator | Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2) Receives: Drug: salbutamol; Other: exercise |
| placebo and exercise | Sham comparator | Subjects undergo exercise training with administration of sham placebo Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Change in body composition (measured by dual energy x ray absorptiometry)
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks
Maximal oxygen consumption (VO2max)
Change in VO2max (measured during bike ergometer cycling to exhaustion)
Measured: Baseline, 2 weeks, 4 weeks and 6 weeks
Secondary outcomes (1)
Salbutamol urine concentration
Concentration of salbutamol in urine
Measured: Before (baseline) as well as 0-1 hours, 1-2 hours, 2-4 hours, 4-8 hours, and 8-16 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start28 Mar 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902106
- Sponsor's protocol ID
- SALB
- Status last verified
- Oct 2020
- First submitted
- 26 Mar 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response to Salbutamol and Exercise
- ClinicalTrials.gov ID
- NCT03902106
- Acronym / sponsor ID
- SALB
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beta2-agonist and exercise | Active comparator | Drug: salbutamol, Other: exerciseSubjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2) |
| placebo and exercise | Sham comparator | Other: exerciseSubjects undergo exercise training with administration of sham placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- VO2max of >55 ml/min/kg for men and >50 ml/min/kg for women
- Body mass index (BMI) < 26
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salbutamolsubjects ingest salbutamol | Drug | beta2-agonist and exercise |
| exercisesubjects undergo 6 weeks of endurance training (3 times weekly) | Other | beta2-agonist and exercise, placebo and exercise |
Primary outcome
Body composition
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Change in body composition (measured by dual energy x ray absorptiometry)
Maximal oxygen consumption (VO2max)
Time frame: Baseline, 2 weeks, 4 weeks and 6 weeks
Change in VO2max (measured during bike ergometer cycling to exhaustion)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salbutamol and exercise in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Baseline, 2 weeks, 4 weeks and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.