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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The objective of this study is to assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKP FlutiForm HFA pMDI | Drug | Each subject will receive SKP FlutiForm HFA pMDI 250/10 microgram twice daily for 60 weeks (two actuations of SKP FlutiForm HFA pMDI 125/5 microgram/actuation) for a total daily dose of 500 microgram fluticasone propionate and 20 microgram formoterol fumarate. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the long-term safety and efficacy of FlutiForm HFA pMDI 250/10 mcg bid in adolescents and adults with moderate to severe asthma who have completed the study SKY2028-3-005 | week 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thao T Doan, MD | Abbott Labs PPD R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Scottsdale | Arizona | 85251 | United States | ||
| Investigational Site |
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|
|
| Orange County |
| California |
| 92868 |
| United States |
| Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| Investigational Site | Valrico | Florida | 33596 | United States |
| Investigational Site | Elizabeth City | North Carolina | 27909 | United States |
| Investigational Site | Medford | Oregon | 97504 | United States |
| Investigational Site | Portland | Oregon | 97213 | United States |
| Investigational Site | East Providence | Rhode Island | 02914 | United States |
| Investigational Site | Providence | Rhode Island | 02906 | United States |
| Investigational Site | West Allis | Wisconsin | 53227 | United States |
| Investigational Site | Guadalajara | Jalisco | 44100 | Mexico |
| Investigational site | Mexico City | Mexico City | 14050 | Mexico |
| Investigational Site | Toluca | State of Mexico | 50080 | Mexico |
| Investigational Site | Villahermosa | Tabasco Mexico | 86100 | Mexico |
| Investigational Site | Zapopan | Zapopan Jalisco | 45200 | Mexico |
| Investigational site | Lima | Lima Province | Lima-01 | Peru |
| Investigational site | Lima | Lima Province | Lima-27 | Peru |
| Investigational site | Lima | Lima Province | Lima-29 | Peru |
| Investigational site | Lima | Lima Province | Lima-31 | Peru |
| Investigational site | Lima | Lima Province | Lima-32 | Peru |
| Investigational site | Lima | Lima Province | Lima-33 | Peru |
| Investigational site | Constanța | Jud. Constanta | 900002 | Romania |
| Investigational site | Craiova | Jud. Dolj | 200515 | Romania |
| Investigational site | Timișoara | Jud. Timis | 300359 | Romania |
| Investigational site | Bucharest | Sector 1 | 010457 | Romania |
| Investigational site | Bucharest | Sector 3 | 030303 | Romania |
| Investigational site | Bucharest | Sector 5 | 050042 | Romania |
| Investigational site | Dnipropetrovsk | 49026 | Ukraine |
| Investigational site | Dnipropetrovsk | 49101 | Ukraine |
| Investigational site | Donetsk | 83017 | Ukraine |
| Investigational site | Donetsk | 83099 | Ukraine |
| Investigational site | Kharkiv | 61035 | Ukraine |
| Investigational site | Kiev | 3680 | Ukraine |
| Investigational site | Kyiv | 02125 | Ukraine |
| Investigational site | Kyiv | 02232 | Ukraine |
| Investigational site | Kyiv | 03680 | Ukraine |
| Investigational site | Lviv | 79010 | Ukraine |
| Investigational site | Vinnytsia | 21029 | Ukraine |
| Investigational site | Zaporizhzhya | 69118 | Ukraine |
| 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 |
|---|---|
| C586520 | fluticasone-formoterol |
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| 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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