Healthy VolunteersPhase 1SALMNCT04195867
Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control
A Phase 1 study testing Salmeterol Xinafoate in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Background: In terms of doping, there is controversy regarding the beneficial effects of β2-agonists like salmeterol on physical performance. Some studies show improvement with salmeterol administered orally, especially related to pulmonary function and muscle contractibility, while other works do not show 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
- Healthy Volunteers
- What is being tested?
- Salmeterol Xinafoate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2018to 8 Jan 2019
- Phase
- Phase 1
- 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 volunteers aged between 18 and 45 years.
- Able to understand and accept the trial procedures and able to sign an informed consent.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed at screening should be within normal limits. Minor or punctual variations of these limits of normality are admitted if, in the opinion of the Principal Investigator, they have no clinical significance, do not pose a risk to the subject and do not interfere with the evaluation of the product in study. These variations and their non-relevance will be justified in writing specifically.
- Body mass index (weight/size^2) between 19 and 26 kg/m2, and weight between 50 and 90 kg. Subjects with BMI >27 kg/m2 may be included at the discretion of the Principal Investigator.
Who cannot join
- Failure to meet the inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any of the excipients. History of serious adverse reactions to other medications.
- Subjects with contraindications to treatment with the study drug (according to Summary of Product Characteristics).
- Background or clinical evidence of psychiatric disorders, alcoholism, regular consumption of psychoactive drugs, drug abuse or addiction to other substances (except for nicotine). Smokers of more than 5 cigarettes/day will be excluded.
- Having participated in another clinical trial with medication in the three months prior to the start of the study.
- Having donated blood during the month prior to the start of the study.
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- Having suffered an organic disease or major surgery in the three months prior to the start of the study.
- Background or clinical evidence of cardiovascular, respiratory (especially asthma or Chronic Obstructive Pulmonary Disease), renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him, may pose a risk to the subjects, may interfere with the objectives of the study or may alter the pharmacokinetics of the drug.
- Have taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to the study sessions will not be exclusive if it is assumed that medication has been completely eliminated on the day of the experimental session.
- Consumption of more than 15 g of alcohol per day.
- Consumers of more than 3 coffees, teas, cola drinks and/or other stimulant drinks (xanthines) per day in the month prior to the start of the study.
- Being unable to understand the nature of the trial and the procedures requested to follow.
- Positive serology for hepatitis B, C or HIV.
Trial locations and contacts
1 site in 1 country.
About this study
Background:
In terms of doping, there is controversy regarding the beneficial effects of β2-agonists like salmeterol on physical performance. Some studies show improvement with salmeterol administered orally, especially related to pulmonary function and muscle contractibility, while other works do not show such ergogenic effects of salmeterol by inhalation.
Read more
Supratherapeutic use of salmeterol is prohibited by the World Anti-Doping Agency, but a maximum allowed urine concentration has not been determined.
Urine concentrations of salmeterol are very low when administered at therapeutic doses, often below the lower limit of quantification. Some studies show that urine concentrations of α-hydroxy-salmeterol (the principal salmeterol metabolite) may be higher than those of the original drug. Thus, α-hydroxy-salmeterol might be a more suitable biomarker for detecting fraudulent use of this drug.
Hypothesis:
Inhaled administration of salmeterol in healthy subjects allows obtaining positive urine samples that will be used to identify analytical strategies for doping detection. Salmeterol concentrations and its metabolites (α-hydroxy-salmeterol and others) can be measured in urine.
Objectives:
Primary objective: To generate urine samples positive to salmeterol in order to be analyzed as control samples by anti-doping laboratories.
Secondary objectives: To identify salmeterol metabolites (α-hydroxy-salmeterol and others) in urine.
Methods:
Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition (salmeterol) administered daily by inhalation to 6 subjects during 3 consecutive days.
- Conditions
- Healthy Volunteers
- Being tested
- Salmeterol Xinafoate
- Keywords
- Salmeterol, Anti-doping control, Athletic performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol XinafoateDrug
Subjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each).
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol | Experimental | Subjects receive a 3-day treatment and collect urine from 2 days before first administration to 24 hours post-administration. Receives: Drug: Salmeterol Xinafoate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in urine concentration of salmeterol
Variation of the concentration of salmeterol in urine
Measured: From 0 hours after first administration to 48 hours after third administration
Secondary outcomes (2)
Changes in urine concentration of α-hydroxy-salmeterol
Variation of the concentration of α-hydroxy-salmeterol in urine
Measured: From 0 hours after first administration to 48 hours after third administration
Changes in urine concentrations of other salmeterol metabolites
Variation of the concentration of other salmeterol metabolites in urine
Measured: From 0 hours after first administration to 48 hours after third administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start20 Nov 2018
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julián A Mateus Rodríguez, MD, Study director, IMIM (Hospital del Mar Medical Research Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195867
- Sponsor's protocol ID
- IMIMFTCL/SALM
- Acronym
- SALM
- Status last verified
- Dec 2019
- First submitted
- 10 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control
- ClinicalTrials.gov ID
- NCT04195867
- Acronym / sponsor ID
- SALM / IMIMFTCL/SALM
- Conditions
- Healthy Volunteers
- Keywords
- Salmeterol, Anti-doping control, Athletic performance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 12 Dec 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.
Background:
In terms of doping, there is controversy regarding the beneficial effects of β2-agonists like salmeterol on physical performance. Some studies show improvement with salmeterol administered orally, especially related to pulmonary function and muscle contractibility, while other works do not show such ergogenic effects of salmeterol by inhalation.
Supratherapeutic use of salmeterol is prohibited by the World Anti-Doping Agency, but a maximum allowed urine concentration has not been determined.
Urine concentrations of salmeterol are very low when administered at therapeutic doses, often below the lower limit of quantification. Some studies show that urine concentrations of α-hydroxy-salmeterol (the principal salmeterol metabolite) may be higher than those of the original drug. Thus, α-hydroxy-salmeterol might be a more suitable biomarker for detecting fraudulent use of this drug.
Hypothesis:
Inhaled administration of salmeterol in healthy subjects allows obtaining positive urine samples that will be used to identify analytical strategies for doping detection. Salmeterol concentrations and its metabolites (α-hydroxy-salmeterol and others) can be measured in urine.
Objectives:
Primary objective: To generate urine samples positive to salmeterol in order to be analyzed as control samples by anti-doping laboratories.
Secondary objectives: To identify salmeterol metabolites (α-hydroxy-salmeterol and others) in urine.
Methods:
Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition (salmeterol) administered daily by inhalation to 6 subjects during 3 consecutive days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salmeterol | Experimental | Drug: Salmeterol XinafoateSubjects receive a 3-day treatment and collect urine from 2 days before first administration to 24 hours post-administration. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male volunteers aged between 18 and 45 years.
- Able to understand and accept the trial procedures and able to sign an informed consent.
- History and physical examination that demonstrate not presenting organic or psychiatric disorders.
- ECG, blood and urine tests performed at screening should be within normal limits. Minor or punctual variations of these limits of normality are admitted if, in the opinion of the Principal Investigator, they have no clinical significance, do not pose a risk to the subject and do not interfere with the evaluation of the product in study. These variations and their non-relevance will be justified in writing specifically.
- Body mass index (weight/size^2) between 19 and 26 kg/m2, and weight between 50 and 90 kg. Subjects with BMI >27 kg/m2 may be included at the discretion of the Principal Investigator.
Key exclusion criteria (13 listed)
- Failure to meet the inclusion criteria.
- History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any of the excipients. History of serious adverse reactions to other medications.
- Subjects with contraindications to treatment with the study drug (according to Summary of Product Characteristics).
- Background or clinical evidence of psychiatric disorders, alcoholism, regular consumption of psychoactive drugs, drug abuse or addiction to other substances (except for nicotine). Smokers of more than 5 cigarettes/day will be excluded.
- Having participated in another clinical trial with medication in the three months prior to the start 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 |
|---|---|---|
| Salmeterol XinafoateSubjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each). | Drug | Salmeterol |
Primary outcome
Changes in urine concentration of salmeterol
Time frame: From 0 hours after first administration to 48 hours after third administration
Variation of the concentration of salmeterol in urine
2 secondary outcomes
Changes in urine concentration of α-hydroxy-salmeterol
Time frame: From 0 hours after first administration to 48 hours after third administration
Changes in urine concentrations of other salmeterol metabolites
Time frame: From 0 hours after first administration to 48 hours after third administration
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 12 Dec 2019.
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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.
Julián A Mateus Rodríguez, MD study director
IMIM (Hospital del Mar Medical Research Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Salmeterol Xinafoate in people with Healthy Volunteers, run by Parc de Salut Mar at 1 site in Spain.
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 5 inclusion and 13 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 12 Dec 2019. 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 Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Changes in urine concentration of salmeterol (time frame: From 0 hours after first administration to 48 hours after third 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 12 Dec 2019.