Exercise Performance
Conditions
Brief summary
The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist indacaterol + mometasonefuroate
Interventions
DRUGIndacaterol and Mometasonefluroate (low dose)
Participants are administered 125 µg indacaterol + mometasonefluroate
DRUGPlacebo
Participants are administered placebo
DRUGIndacaterol and Mometasonefluroate (high dose)
Participants are administered 500 µg indacaterol + mometasonefluroate
Sponsors
Morten Hostrup, PhD
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-39 * Physically active \> 5 h weekly * Maximal oxygen consumption classified as high or very high
Exclusion criteria
* 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 * FEV1/FVC ratio \< 0.7 determined with spirometry * Chronic illness determined to be a potential risk for participant during study * In chronic treatment with medication that may interfere with study results * Pregnancy * Smoker * Blood donation during the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Power output during sprint testing | Through study completion, an average of 3 weeks | Power output measured in Watts during a sprint on a bike ergometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Power output during time trial | Through study completion, an average of 3 weeks | Mean power output measured in Watts during a time trial on a bike ergometer |
| Forced Expiratory Volume in 1 second (FEV1) | Through study completion, an average of 3 weeks | FEV1 measured by spirometry |
| Quadriceps strength | Through study completion, an average of 3 weeks | Maximal torque (Nm) achieved during isometric contraction |
| Respiratory muscle function | Through study completion, an average of 3 weeks | Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter) |
Countries
Denmark
Contacts
Primary ContactMorten Hostrup, PhD
Outcome results
None listed