HealthyNCT06655012
Salmeterol Effect on Exercise Performance
A study testing Salmeterol in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salmeterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40
- Physically active >5 hours a week
- Maximum oxygen uptake classified as high or very high
Who cannot join
- Active smoker currently or within the past 5 years
- Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
- Chronic or acute illness deemed by the responsible study physician to affect the test parameters
- Deviation from the study protocol
- Lean mass index >21 kg/m²
- Pregnancy
- Smoker
- Blood donation during the past 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
August Krogh Building
Copenhagen, 2100
Morten Hostrup, PhD, +4535321595, mhostrup@nexs.ku.dk
About this study
Official title: The Muscle Anabolic Response to β2-adrenergic Stimulation
The purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women.
- Conditions
- Healthy
- Being tested
- Salmeterol, Placebo
- Keywords
- Beta2-adrenergic stimulation, Skeletal muscle hypertrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalmeterolDrug
Participants are administered 200 µg salmeterol (8 puffs) from a MDI device
PlaceboDrug
Participants are administered placebo (8 puffs) from a MDI device
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol | Experimental | Participants are administered salmeterol from an inhaler device Receives: Drug: Salmeterol |
| Placebo | Placebo comparator | Participants are administered placebo from an inhaler device Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power output during sprint testing
Power output measured in Watts during a sprint on a bike ergometer
Measured: Through study completion, an average on 2 weeks
Secondary outcomes (1)
Power output during time trial
Mean power output measured in Watts during a time trial on a bike ergometer
Measured: Through study completion, an average on 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start31 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT06655012
- Sponsor's protocol ID
- SALM_acute
- Status last verified
- Apr 2025
- First submitted
- 22 Oct 2024
- Last updated
- 9 Apr 2025
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Muscle Anabolic Response to β2-adrenergic Stimulation
- ClinicalTrials.gov ID
- NCT06655012
- Acronym / sponsor ID
- SALM_acute
- Conditions
- Healthy
- Keywords
- Beta2-adrenergic stimulation, Skeletal muscle hypertrophy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Oct 2024 (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 purpose of the project is to investigate the muscle anabolic response to acute beta2-adrenergic stimulation in young healthy men and women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmeterol | Experimental | Drug: SalmeterolParticipants are administered salmeterol from an inhaler device |
| Placebo | Placebo comparator | Drug: PlaceboParticipants are administered placebo from an inhaler device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-40
- Physically active >5 hours a week
- Maximum oxygen uptake classified as high or very high
Key exclusion criteria (8 listed)
- Active smoker currently or within the past 5 years
- Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
- Chronic or acute illness deemed by the responsible study physician to affect the test parameters
- Deviation from the study protocol
- Lean mass index >21 kg/m²
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 |
|---|---|---|
| SalmeterolParticipants are administered 200 µg salmeterol (8 puffs) from a MDI device | Drug | Salmeterol |
| PlaceboParticipants are administered placebo (8 puffs) from a MDI device | Drug | Placebo |
Primary outcome
Power output during sprint testing
Time frame: Through study completion, an average on 2 weeks
Power output measured in Watts during a sprint on a bike ergometer
1 secondary outcome
Power output during time trial
Time frame: Through study completion, an average on 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salmeterol 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 8 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Power output during sprint testing (time frame: Through study completion, an average on 2 weeks). 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 9 Apr 2025.