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To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, in adult and adolescent patients with mild to moderate asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FlutiForm 100/10ug |
|
| 2 | Experimental | Fluticasone 100 |
|
| 3 | Active Comparator | Formoterol 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate/Formoterol Fumarate 100/10 | Drug | FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 | Week 0 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Other pulmonary function tests including forced vital capacity (FVC) and peak expiratory flow rate (PEFR). | Whole duration of study | |
| Clinical endpoints (frequency of asthma exacerbations and patient data captured in diary including daily morning and evening PEFR). |
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Inclusion Criteria:
Exclusion Criteria:
Patients will not be eligible for the study if they meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35242 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23870606 | Derived | Pearlman DS, LaForce CF, Kaiser K. Fluticasone/Formoterol combination therapy compared with monotherapy in adolescent and adult patients with mild to moderate asthma. Clin Ther. 2013 Jul;35(7):950-66. doi: 10.1016/j.clinthera.2013.05.012. |
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|
| Fluticasone propionate 100 | Drug | Fluticasone 100 is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. |
|
|
| Formoterol fumarate 10 | Drug | Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
|
|
| Whole duration of study |
| Safety variables include adverse events, ECGs, clinical laboratory tests and vital signs. | Whole duration of study |
| Mission Viejo |
| California |
| 92691 |
| United States |
| Research Site | Orange | California | 92868 | United States |
| Research Site | San Jose | California | 95117 | United States |
| Research Site | Vista | California | 92083 | United States |
| Research Site | Denver | Colorado | 80230 | United States |
| Research Site | Lilburn | Georgia | 30047 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Park City | Kansas | 67219 | United States |
| Research Site | Bethesda | Maryland | 20814 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Center | Stevensville | Michigan | 49127 | United States |
| Research Site | Elizabeth | New Jersey | 07202 | United States |
| Research Center | Rochester | New York | 14618 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Site | Raleigh | North Carolina | 27607 | United States |
| Research Site | Cincinnati | Ohio | 45242 | United States |
| Research Site | Sylvania | Ohio | 43560 | United States |
| Research Site | Easton | Pennsylvania | 18045 | United States |
| Research Site | Lincoln | Rhode Island | 02906 | United States |
| Research Site | Greenville | South Carolina | 29605 | United States |
| Research Site | Chattanooga | Tennessee | 37421 | United States |
| Research Site | El Paso | Texas | 79902 | United States |
| Research Site | Houston | Texas | 77054 | United States |
| Research Site | Katy | Texas | 77450 | United States |
| Research Site | New Braunfels | Texas | 78130 | United States |
| Research Site | Waco | Texas | 76712 | United States |
| Research Site | South Burlington | Vermont | 05403 | United States |
| Research Site | Greenfield | Wisconsin | 53228 | United States |
| Research Site | Kelowna | British Columbia | V1Y 9L8 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 3J5 | Canada |
| Research Site | Hamilton | Ontario | L8N 1Y2 | Canada |
| Research Center | London | Ontario | N5X 4E7 | Canada |
| Research Site | London | Ontario | N6A 1V2 | Canada |
| Research Site | Mississauga | Ontario | L4W 1N2 | Canada |
| Research Site | Oshawa | Ontario | L1H 1B9 | Canada |
| Research Site | Toronto | Ontario | M4P 1P2 | Canada |
| Research Site | Longueuil | Quebec | J4N 1E1 | Canada |
| Research Site | Montreal | Quebec | H2L 2W5 | Canada |
| Research Site | Saint Foy | Quebec | G1V 4M6 | Canada |
| Research Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| 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 |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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