U-LABA/ICS Effects on Exercise Performance, Indacaterol

Study Overview
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Brief Summary
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The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist indacaterol + mometasonefuroate

Official Title
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Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Indacaterol

Conditions
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Exercise Performance

Intervention / Treatment
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* Drug: Indacaterol and Mometasonefluroate (low dose)
* Drug: Placebo
* Drug: Indacaterol and Mometasonefluroate (high dose)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol + mometasonefluroate<br> | Drug: Indacaterol and Mometasonefluroate (low dose)<br>* Participants are administered 125 µg indacaterol + mometasonefluroate<br>Drug: Indacaterol and Mometasonefluroate (high dose)<br>* Participants are administered 500 µg indacaterol + mometasonefluroate<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Participants are administered placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power output during sprint testing | Power output measured in Watts during a sprint on a bike ergometer | Through study completion, an average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power output during time trial | Mean power output measured in Watts during a time trial on a bike ergometer | Through study completion, an average of 3 weeks | 
| Forced Expiratory Volume in 1 second (FEV1) | FEV1 measured by spirometry | Through study completion, an average of 3 weeks | 
| Quadriceps strength | Maximal torque (Nm) achieved during isometric contraction | Through study completion, an average of 3 weeks | 
| Respiratory muscle function | Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter) | Through study completion, an average of 3 weeks |