Pharmacokinetics in Healthy Young MenPhase 4NCT02558088
Pharmacological Properties of Salmeterol
A Phase 4 study testing Salmeterol in people with Pharmacokinetics in Healthy Young Men, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports. Hence, there is no hypothesis as such. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics in Healthy Young Men
- What is being tested?
- Salmeterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Jul 2016
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-45 years
- Healthy
Who cannot join
- Chronic disease
- Smoking
- Habitual use of medicine
- Allergy towards salmeterol
- Unable to exercise on a bike ergometer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Properties of Inhaled Salmeterol in Healthy Trained Males
The objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports.
Hence, there is no hypothesis as such.
- Conditions
- Pharmacokinetics in Healthy Young Men
- Being tested
- Salmeterol
- Keywords
- salmeterol, pharmacokinetics, doping, beta2-agonists, long-acting beta2-agonists
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalmeterolDrug
| Study group | Role | What they receive |
|---|---|---|
| salmeterol | Experimental | Not described Receives: Drug: Salmeterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine concentration of salmeterol
Measured: 0-24 hours after administration of the study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics in Healthy Young MenStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Nielsen, University of Copenhagen
- Investigators
- Vibeke Backer, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558088
- Sponsor's protocol ID
- WADA2013sal
- Status last verified
- Jan 2017
- First submitted
- 12 Sep 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Properties of Inhaled Salmeterol in Healthy Trained Males
- ClinicalTrials.gov ID
- NCT02558088
- Acronym / sponsor ID
- WADA2013sal
- Conditions
- Pharmacokinetics in Healthy Young Men
- Keywords
- salmeterol, pharmacokinetics, doping, beta2-agonists, long-acting beta2-agonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 23 Sep 2015 (estimated)
- 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 objective of the study is to help establish a urinary threshold for salmeterol on the World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in competitive sports.
Hence, there is no hypothesis as such.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| salmeterol | Experimental | Drug: Salmeterol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18-45 years
- Healthy
Key exclusion criteria (5 listed)
- Chronic disease
- Smoking
- Habitual use of medicine
- Allergy towards salmeterol
- Unable to exercise on a bike ergometer
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 |
|---|---|---|
| Salmeterol | Drug | salmeterol |
Primary outcome
Urine concentration of salmeterol
Time frame: 0-24 hours after administration of the study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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.
Vibeke Backer, Professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salmeterol in people with Pharmacokinetics in Healthy Young Men, 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 5 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: finished, as of the sponsor's last update on 31 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urine concentration of salmeterol (time frame: 0-24 hours after administration of the study drug). 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 31 Jan 2017.