AsthmaPhase 4SALBEXONCT02655328
Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping
A Phase 4 study testing blood sample and urine sample in people with Asthma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Asthma
- What is being tested?
- blood sample and urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Jul 2013
- 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 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- patient who hold a license in a sport federation, and do at least 8 hours of sport each week
- asthmatic patient
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.
- Conditions
- Asthma
- Being tested
- blood sample, urine sample
- Keywords
- asthma, athlete
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
blood sample
urine sampleOther
urine sample
| Study group | Role | What they receive |
|---|---|---|
| athlete under asthma treatment | Experimental | athlete suffering from asthma blood sample urine sample Receives: Other: blood sample; Other: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of exercise on pharmacokinetics profile
impact of exercise on pharmacokinetics profile of salbutamol concentration in urine
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startMar 2009
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Rivière, MD, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655328
- Sponsor's protocol ID
- 08 301 03
- Acronym
- SALBEXO
- Status last verified
- Jan 2016
- First submitted
- 10 Jul 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping
- ClinicalTrials.gov ID
- NCT02655328
- Acronym / sponsor ID
- SALBEXO / 08 301 03
- Conditions
- Asthma
- Keywords
- asthma, athlete
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Jan 2016 (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.
This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| athlete under asthma treatment | Experimental | Other: blood sample, Other: urine sampleathlete suffering from asthma blood sample urine sample |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patient who hold a license in a sport federation, and do at least 8 hours of sport each week
- asthmatic patient
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| blood sampleblood sample | Other | athlete under asthma treatment |
| urine sampleurine sample | Other | athlete under asthma treatment |
Primary outcome
impact of exercise on pharmacokinetics profile
Time frame: 4 days
impact of exercise on pharmacokinetics profile of salbutamol concentration in urine
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 14 Jan 2016.
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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.
Daniel Rivière, MD principal investigator
UH Toulouse
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 blood sample and urine sample in people with Asthma, run by University Hospital, Toulouse at 1 site in France.
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 2 inclusion and 1 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 14 Jan 2016. 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 France. 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?
impact of exercise on pharmacokinetics profile (time frame: 4 days). 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 14 Jan 2016.