NCT02655328

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_4 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

4.3 years

First QC Date

July 10, 2015

Last Update Submit

January 11, 2016

Conditions

Asthma

Keywords

asthmaathlete

Outcome Measures

Primary Outcomes (1)

  • impact of exercise on pharmacokinetics profile

    impact of exercise on pharmacokinetics profile of salbutamol concentration in urine

    4 days

Study Arms (1)

athlete under asthma treatment

EXPERIMENTAL

athlete suffering from asthma blood sample urine sample

Other: blood sampleOther: urine sample

Interventions

blood sampleOTHER

blood sample

athlete under asthma treatment
urine sampleOTHER

urine sample

athlete under asthma treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patient who hold a license in a sport federation, and do at least 8 hours of sport each week
  • asthmatic patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Toulouse

Toulouse, 31, France

Location

MeSH Terms

Conditions

Asthma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Daniel Rivière, MD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2015

First Posted

January 14, 2016

Study Start

March 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

FR(1)