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NCT02655328 Clinical Trial

Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping

Asthma Clinical Trial

— SALBEXO  

Official title:
Diagnosis et Treatment of Asthma in Athlete : Boundary Between Disease and Doping

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02655328
Other study ID # 08 301 03
Secondary ID
Status Completed
Phase Phase 4
First received July 10, 2015
Last updated January 11, 2016
Start date March 2009
Est. completion date July 2013

Study information
Verified date January 2016
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

This study will determine the pharmacokinetic profile of the salbutamol concentration in the urine while athletes are resting or during exercise.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• blood sample
blood sample
• urine sample
urine sample

Locations
Country Name City State
France UH Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary impact of exercise on pharmacokinetics profile impact of exercise on pharmacokinetics profile of salbutamol concentration in urine 4 days No
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