U-LABA/ICS Effects on Exercise Performance, Vilanterol
ConditionExercise Performance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorMorten Hostrup, PhD
About this trial
The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-39
Physically active > 5 h weekly
Maximal oxygen consumption classified as high or very high
Disqualifiers
Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
ECG abnormality
ACQ score > 1.5
Severe bronchial hyperreactivity as determined by mannitol test
Trial design
Design model
Crossover
Treatments tested in this trial
Vilanterol and Fluticasone Furoate (low dose)
DrugParticipants are administered 25 µg of vilanterol + fluticasone furoate
Vilanterol and Fluticasone Furoate (high dose)
DrugParticipants are administered 100 µg of vilanterol + fluticasone furoate
Placebo
DrugParticipants are administered placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Vilanterol + fluticasone furoateExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Power output during sprint testing
Power output measured in Watts during a sprint on a bike ergometer
Time frame
Through study completion, an average of 3 weeksSecondary outcomes
1
Power output during time trial
Mean power output measured in Watts during a time trial on a bike ergometer
Time frame
Through study completion, an average of 3 weeksOther outcomes
1
Forced Expiratory Volume in 1 second (FEV1)
FEV1 measured by spirometry
Time frame
Through study completion, an average of 3 weeks2
Quadriceps strength
Maximal torque (Nm) achieved during isometric contraction
Time frame
Through study completion, an average of 3 weeks3
Respiratory muscle function
Mouth inspiratory and expiratory pressures against a closed system
Time frame
Through study completion, an average of 3 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Morten Hostrup, PhD
Lead sponsor
University of Copenhagen
Sponsor institution
Source ClinicalTrials.gov