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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort - usual care | Experimental | Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. |
|
| Formoterol - inhalation | Experimental | Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally. |
|
| Formoterol - oral | Experimental | Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device. |
|
| Placebo | Placebo Comparator | Participants are administered placebo from an inhaler device testing and a placebo capsule. |
|
| Mannitol-test | Experimental | Participants are administered Bronchitol from an inhaler device testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort | Drug | Participants are administered 54 μg Formoterol and 1920 μg Budesonide |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps strength | Maksimal torque (Nm) achieved during isometric contraction | Through study completion, an average on 4 weeks |
| Forced Expiratory Volume in 1 second (FEV1) | FEV1 measured by spirometry |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morten Hostrup, PhD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| August Krogh Building | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D000068759 | Formoterol Fumarate |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Formoterol | Drug | Participants are administered 54 μg Formoterol from an inhaler device |
|
| Formoterol | Drug | Participants are administered 120 μg Formoterol in a capsule, which is taken orally |
|
| Placebo | Drug | Participants are administered placebo |
|
| Mannitol | Drug | Participants are administered 600 mg Bronchitol |
|
| Through study completion, an average on 4 weeks |
| Respiratory muscle function | Mouth inspiratory and expiratory pressures against a closed system | Through study completion, an average on 4 weeks |
| D000588 |
| Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D013402 | Sugar Alcohols |
| D002241 | Carbohydrates |