Exercise Performance
Conditions
Brief summary
The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate
Interventions
Participants inhale 25 µg vilanterol + fluticasone furoate daily
DRUGIndacaterol and Mometasone Furoate
Participants inhale 125 µg indacaterol + mometasone furoate daily
DRUGPlacebo
Participants inhale placebo daily
Sponsors
Morten Hostrup, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 |
|---|---|---|
| Exercise capacity during a time trial | Through study completion, an average of 8 weeks | Mean power output measured in Watts during a time trial on a bike ergometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function | Through study completion, an average of 8 weeks | Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exercise induced bronchial hyper reactivity | Through study completion, an average of 8 weeks | Assessed by decreases in FEV1 after maximal exercise |
| Quadriceps muscle strength | Through study completion, an average of 8 weeks | Assessed by maximal isometric contraction torque |
| Airway inflammation | Through study completion, an average of 8 weeks | Measured by fractional nitric oxide in expired air |
| Fat mass | Through study completion, an average of 8 weeks | Measured with DXA-scanning |
| Lean body mass | Through study completion, an average of 8 weeks | Measured with DXA-scanning |
| Mannitol induced bronchial hyper reactivity | Through study completion, an average of 8 weeks | Assessed by decreases in FEV1 as dose response to cumulative doses of mannitol |
Countries
Denmark
Contacts
Primary ContactMorten Hostrup, PhD
Outcome results
None listed