- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655328
Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping (SALBEXO)
January 11, 2016 updated by: University Hospital, Toulouse
This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31
- UH Toulouse
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- patient who hold a license in a sport federation, and do at least 8 hours of sport each week
- asthmatic patient
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: athlete under asthma treatment
athlete suffering from asthma blood sample urine sample
|
blood sample
urine sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
impact of exercise on pharmacokinetics profile
Time Frame: 4 days
|
impact of exercise on pharmacokinetics profile of salbutamol concentration in urine
|
4 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Rivière, MD, UH Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
July 10, 2015
First Submitted That Met QC Criteria
January 11, 2016
First Posted (Estimate)
January 14, 2016
Study Record Updates
Last Update Posted (Estimate)
January 14, 2016
Last Update Submitted That Met QC Criteria
January 11, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08 301 03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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