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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The primary purpose of this study is to evaluate the early bronchodilating effect of SKP FlutiForm HFA pMDI compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Placebo Comparator |
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| II | Placebo Comparator |
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| III | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone propionate, formoterol fumarate | Drug | ● Period 1 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 2 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 3 Treatment Regimen C: placebo SKP placebo; (two actuations) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline FEV1 to post study drug dosing FEV1 | 3 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline FEV1 to post study drug dosing FEV1 | 8, 15, 30, and 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Anaheim | California | 92801 | United States | ||
| Investigational Site |
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| fluticasone propionate, formoterol fumarate | Other | ● Period 1 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) ● Period 2 Treatment Regimen C: placebo SKP placebo; (two actuations) ● Period 3 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) |
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| fluticasone propionate, formoterol fumarate | Other | ● Period 1 Treatment Regimen C: placebo SKP placebo; (two actuations) ● Period 2 Treatment Regimen A: FlutiForm 250/10 ug FlutiForm HFA pMDI (250/10 ug); (two actuations of FlutiForm HFA pMDI 125/5 ug/actuation) ● Period 3 Treatment Regimen B: FlutiForm 100/10 ug FlutiForm HFA pMDI (100/10 ug); (two actuations of FlutiForm HFA pMDI 50/5 ug/actuation) |
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| Mission Viejo |
| California |
| 92691 |
| United States |
| Investigational Site | Denver | Colorado | 80230 | United States |
| Investigational Site | Valrico | Florida | 33594 | United States |
| Investigational Site | Medford | Oregon | 97504 | United States |
| Investigational Site | Portland | Oregon | 97213 | United States |
| Investigational Site | Richmond | Virginia | 23229 | United States |
| Investigational Site | West Allis | Wisconsin | 53227 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| C586520 | fluticasone-formoterol |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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