U-LABA/ICS Effects on Exercise Performance, Indacaterol
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 indacaterol + mometasonefuroate
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
Indacaterol and Mometasonefluroate (low dose)
DrugParticipants are administered 125 µg indacaterol + mometasonefluroate
Placebo
DrugParticipants are administered placebo
Indacaterol and Mometasonefluroate (high dose)
DrugParticipants are administered 500 µg indacaterol + mometasonefluroate
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Indacaterol + mometasonefluroateExperimental 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 weeks2
Forced Expiratory Volume in 1 second (FEV1)
FEV1 measured by spirometry
Time frame
Through study completion, an average of 3 weeks3
Quadriceps strength
Maximal torque (Nm) achieved during isometric contraction
Time frame
Through study completion, an average of 3 weeks4
Respiratory muscle function
Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter)
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