HealthyNCT06657547
Urinary Concentration After Salmeterol
A study testing Normal conditions, Heated conditions and Salmeterol inhalation and urine samples in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the project is to investigate urine concentration after inhalation of salmeterol. This will be examined following acute physical activity under both normal conditions and heated conditions. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Healthy
- What is being tested?
- Normal conditions, Heated conditions and Salmeterol inhalation and urine samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 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
- No healthy volunteers
- 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: Urinary Concentration After Salmeterol in Well-trained Men and Females
The purpose of the project is to investigate urine concentration after inhalation of salmeterol. This will be examined following acute physical activity under both normal conditions and heated conditions.
- Conditions
- Healthy
- Being tested
- Normal conditions, Heated conditions, Salmeterol inhalation and urine samples
- Keywords
- Urinary concentration, Beta2-adrenergic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal conditionsOther
Participants are administered salmeterol, after which they perform various performance tests in normal conditions. Following the administration of salmeterol, urine samples are collected over the next 24 hours at intervals of 0.5, 1, 2, 4, 8, and 24 hours after administration.
Heated conditionsOther
Participants are administered salmeterol, after which they perform various performance tests in heated conditions. Following the administration of salmeterol, urine samples are collected over the next 24 hours at intervals of 0.5, 1, 2, 4, 8, and 24 hours after administration.
Salmeterol inhalation and urine samplesDrug
After the experimental day under normal conditions, all participants are administered 200 µg of salmeterol daily (8 puffs from the MDI device) during a 6-day intervention period. Two hours after inhalation, the participants collect spot urine samples at home
| Study group | Role | What they receive |
|---|---|---|
| Normal conditions | Active comparator | Urine samples collected after various performance tests in normal conditions Receives: Other: Normal conditions |
| Heated conditions | Experimental | Urine samples collected after various performance tests in heated conditions Receives: Other: Heated conditions |
| Salmeterol inhalation and urine samples | Other | Participants are administered daily salmeterol inhalation from an MDI device and are required to collect spot urine samples at home. Receives: Drug: Salmeterol inhalation and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration
Difference in urine concentration with salmeterol administered before performance tests in different conditions
Measured: Through study completion, an average on 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06657547
- Sponsor's protocol ID
- SALM_urine
- Status last verified
- Apr 2025
- First submitted
- 23 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
- Urinary Concentration After Salmeterol in Well-trained Men and Females
- ClinicalTrials.gov ID
- NCT06657547
- Acronym / sponsor ID
- SALM_urine
- Conditions
- Healthy
- Keywords
- Urinary concentration, Beta2-adrenergic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 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
- 24 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 urine concentration after inhalation of salmeterol. This will be examined following acute physical activity under both normal conditions and heated conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal conditions | Active comparator | Other: Normal conditionsUrine samples collected after various performance tests in normal conditions |
| Heated conditions | Experimental | Other: Heated conditionsUrine samples collected after various performance tests in heated conditions |
| Salmeterol inhalation and urine samples | Other | Drug: Salmeterol inhalation and urine samplesParticipants are administered daily salmeterol inhalation from an MDI device and are required to collect spot urine samples at home. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Normal conditionsParticipants are administered salmeterol, after which they perform various performance tests in normal conditions. Following the administration of salmeterol, urine samples are collected over the next 24 hours at intervals of 0.5, 1, 2, 4, 8, and 24 hours after administration. | Other | Normal conditions |
| Heated conditionsParticipants are administered salmeterol, after which they perform various performance tests in heated conditions. Following the administration of salmeterol, urine samples are collected over the next 24 hours at intervals of 0.5, 1, 2, 4, 8, and 24 hours after administration. | Other | Heated conditions |
| Salmeterol inhalation and urine samplesAfter the experimental day under normal conditions, all participants are administered 200 µg of salmeterol daily (8 puffs from the MDI device) during a 6-day intervention period. Two hours after inhalation, the participants collect spot urine samples at home | Drug | Salmeterol inhalation and urine samples |
Primary outcome
Urine concentration
Time frame: Through study completion, an average on 1 week
Difference in urine concentration with salmeterol administered before performance tests in different conditions
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 Normal conditions, Heated conditions and Salmeterol inhalation and urine samples 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. 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?
Contact Morten Hostrup, PhD (+4535321595, mhostrup@nexs.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine concentration (time frame: Through study completion, an average on 1 week). 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; AzTrials last refreshed its copy on 28 Oct 2026.