U-LABA/ICS Effects on Exercise Performance, Formoterol

Study Overview
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Brief Summary
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The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.

Official Title
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Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol

Conditions
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Exercise Performance

Intervention / Treatment
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* Drug: Symbicort
* Drug: Formoterol
* Drug: Formoterol
* Drug: Placebo
* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-45 Physically active >5 hours a week Maximum oxygen uptake classified as high or very high Exclusion Criteria: Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid ECG abnormality FEV1/FVC ratio < 0,7 determined with spirometry Chronic illness determined to be a potential risk for participant during the study In chronic treatments 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: 45 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: Symbicort - usual care<br>Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. | Drug: Symbicort<br>* Participants are administered 54 μg Formoterol and 1920 μg Budesonide<br>|
| Experimental: Formoterol - inhalation<br>Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. | Drug: Formoterol<br>* Participants are administered 54 μg Formoterol from an inhaler device<br>|
| Experimental: Formoterol - oral<br>Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device. | Drug: Formoterol<br>* Participants are administered 120 μg Formoterol in a capsule, which is taken orally<br>|
| Placebo Comparator: Placebo<br>Participants are administered placebo from an inhaler device testing and a placebo capsule. | Drug: Placebo<br>* Participants are administered placebo<br>|
| Experimental: Mannitol-test<br>Participants are administered Bronchitol from an inhaler device testing. | Drug: Mannitol<br>* Participants are administered 600 mg Bronchitol<br>|

What is the study measuring?
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Primary 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 on 4 weeks | 

Secondary 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 on 4 weeks |