HealthyNCT04615611
Physiologic Performance Response to Salbutamol
A study testing salbutamol in people with Healthy, run by University of Copenhagen.
Trial summary
This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 7 Nov 2020to 7 Nov 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
- 18 to 45 years of age
- Trained individuals with maximal oxygen uptake above 55 mL/kg/min for men and 50 mL/kg/min for women
- Body mass index lower than 26
Who cannot join
- Allergy towards study drug
- Unacceptable side effects of the study drug
- Chronic disease deemed by the MD to impose a risk or severely confound the study outcomes
- Current smokers
- Use of prescription medicine
- Pregnancy
About this study
Official title: Individual beta2-adrenergic Performance Response to Salbutamol
This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes
- Conditions
- Healthy
- Being tested
- salbutamol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salbutamolDrug
inhalation of salbutamol
PlaceboDrug
administration of placebo
| Study group | Role | What they receive |
|---|---|---|
| salbutamol | Experimental | salbutamol, 800 microgram from metered dose inhaler Receives: Drug: salbutamol |
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sprint performance
Power output during maximal cycling
Measured: Measured ½ hour after drug administration
Secondary outcomes (3)
Muscle strength
Quadriceps maximal voluntary contraction
Measured: Measured ½ hour after drug administration
Sprint fatigue tolerance
Fatigue index during maximal cycling
Measured: Measured ½ hour after drug administration
Cycling endurance performance
4-min time trial on bike ergometer
Measured: Measured ½ hour after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start7 Nov 2020 (estimated)
- Primary completion7 Nov 2021 (estimated)
- Study completion7 Nov 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.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT04615611
- Sponsor's protocol ID
- SAL-POWER
- Status last verified
- Oct 2020
- First submitted
- 29 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual beta2-adrenergic Performance Response to Salbutamol
- ClinicalTrials.gov ID
- NCT04615611
- Acronym / sponsor ID
- SAL-POWER
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 7 Nov 2020 (estimated)
- Primary completion
- 7 Nov 2021 (estimated)
- Study completion
- 7 Nov 2021 (estimated)
- First posted
- 4 Nov 2020 (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.
This project aims to investigate the individual physiological response to beta2-adrenergic stimulation with salbutamol on performance-related outcomes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| salbutamol | Experimental | Drug: salbutamolsalbutamol, 800 microgram from metered dose inhaler |
| placebo | Placebo comparator | Drug: Placeboplacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 to 45 years of age
- Trained individuals with maximal oxygen uptake above 55 mL/kg/min for men and 50 mL/kg/min for women
- Body mass index lower than 26
Key exclusion criteria (6 listed)
- Allergy towards study drug
- Unacceptable side effects of the study drug
- Chronic disease deemed by the MD to impose a risk or severely confound the study outcomes
- Current smokers
- Use of prescription medicine
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 |
|---|---|---|
| salbutamolinhalation of salbutamol | Drug | salbutamol |
| Placeboadministration of placebo | Drug | placebo |
Primary outcome
Sprint performance
Time frame: Measured ½ hour after drug administration
Power output during maximal cycling
3 secondary outcomes
Muscle strength
Time frame: Measured ½ hour after drug administration
Sprint fatigue tolerance
Time frame: Measured ½ hour after drug administration
Cycling endurance performance
Time frame: Measured ½ hour after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing salbutamol in people with Healthy, run by University of Copenhagen.
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 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sprint performance (time frame: Measured ½ hour after drug administration). 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 4 Nov 2020.