Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilanterol | Experimental | Participants inhale vilanterol + fluticasone furoat |
|
| Indacaterol | Experimental | Participants inhale indacaterol + mometasone furoate |
|
| Placebo | Placebo Comparator | Participants inhale placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilanterol and Fluticasone Furoate | Drug | Participants inhale 25 µg vilanterol + fluticasone furoate daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity during a time trial | Mean power output measured in Watts during a time trial on a bike ergometer | Through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function | Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation | Through study completion, an average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Airway inflammation | Measured by fractional nitric oxide in expired air | Through study completion, an average of 8 weeks |
| Mannitol induced bronchial hyper reactivity | Assessed by decreases in FEV1 as dose response to cumulative doses of mannitol |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Hostrup, PhD | Contact | +4535321595 | mhostrup@nexs.ku.dk |
| Name | Affiliation | Role |
|---|---|---|
| Morten Hostrup, PhD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| August Krogh Building | Recruiting | Copenhagen | 2100 | Denmark |
Deidentified data set will be shared upon reasonable request.
Deidentified data set will be shared upon reasonable request.
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C550468 | vilanterol |
| C523187 | fluticasone furoate |
| C510790 | indacaterol |
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Indacaterol and Mometasone Furoate | Drug | Participants inhale 125 µg indacaterol + mometasone furoate daily |
|
| Placebo | Drug | Participants inhale placebo daily |
|
| Through study completion, an average of 8 weeks |
| Exercise induced bronchial hyper reactivity | Assessed by decreases in FEV1 after maximal exercise | Through study completion, an average of 8 weeks |
| Quadriceps muscle strength | Assessed by maximal isometric contraction torque | Through study completion, an average of 8 weeks |
| Lean body mass | Measured with DXA-scanning | Through study completion, an average of 8 weeks |
| Fat mass | Measured with DXA-scanning | Through study completion, an average of 8 weeks |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |