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The purpose of this study is 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, and with placebo in adult and adolescent patients with mild to moderate asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FlutiForm 100/10 μg |
|
| 2 | Active Comparator | Fluticasone 100 μg |
|
| 3 | Active Comparator | Formoterol 10 μg |
|
| 4 | Placebo Comparator | Placebo |
|
| 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) over 12 weeks recorded in electronic diary. Discontinuation due to lack of efficacy | Week 0 and 12 visits |
| 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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Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring or steroid-free.
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Pell City | Alabama | 35128 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23078148 | Derived | Nathan RA, D'Urzo A, Blazhko V, Kaiser K. Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial. BMC Pulm Med. 2012 Oct 18;12:67. doi: 10.1186/1471-2466-12-67. |
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|
| Fluticasone propionate 100 | Drug | Fluticasone 100ug 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. |
|
|
| Placebo | Drug | Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks. |
|
|
| Whole duration of study |
| Safety variables including adverse events, ECGs, clinical laboratory tests and vital signs. | Whole duration of study |
| Serial 12-hour FEV-1 area under the curve (AUC). | Week 0, 2 and 12 visits |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Research Site | Cypress | California | 90630 | United States |
| Research Site | Encinitas | California | 92024 | United States |
| Research Site | Fountain Valley | California | 92708 | United States |
| Research Center | Los Angeles | California | 90048 | United States |
| Research Site | Mission Hills | California | 91345 | United States |
| Research Site | Centennial | Colorado | 80112 | United States |
| Research Site | Colorado Springs | Colorado | 80907 | United States |
| Research Site | Englewood | Colorado | 80112 | United States |
| Research Site | Waterbury | Connecticut | 06708 | United States |
| Research Site | Aventura | Florida | 33180 | United States |
| Research Site | Gainesville | Florida | 32610 | United States |
| Research Center | Largo | Florida | 33770 | United States |
| Research Site | Miami | Florida | 33176 | United States |
| Research Site | Ocala | Florida | 34471 | United States |
| Research Site | Tallahassee | Florida | 32308 | United States |
| Research Site | Conyers | Georgia | 30012 | United States |
| Research Site | Lawrenceville | Georgia | 32308 | United States |
| Research Site | Round Lake Beach | Illinois | 60073 | United States |
| Research Site | Indianapolis | Indiana | 46208 | United States |
| Research Site | Bethesda | Maryland | 20814 | United States |
| Research Site | Brockton | Massachusetts | 02301 | United States |
| Research Site | Cherry Hill | New Jersey | 08003 | United States |
| Research Site | Forked River | New Jersey | 08732 | United States |
| Research Site | Asheville | North Carolina | 28801 | United States |
| Research Center | Elizabeth City | North Carolina | 27909 | United States |
| Research Site | Elizabeth City | North Carolina | 27909 | United States |
| Research Site | Columbus | Ohio | 43235 | United States |
| Research Site | Toledo | Ohio | 43617 | United States |
| Research Site | Okalahoma City | Oklahoma | 73139 | United States |
| Research Site | Oklahoma City | Oklahoma | 73104 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Eugene | Oregon | 97401 | United States |
| Research Site | Lake Oswego | Oregon | 97035 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Site | Philadelphia | Pennsylvania | 19115 | United States |
| Research Site | Pittsburgh | Pennsylvania | 15241 | United States |
| Research Site | Scranton | Pennsylvania | 18509 | United States |
| Research Site | Austin | Texas | 78750 | United States |
| Research Site | Dallas | Texas | 75246 | United States |
| Research Site | El Paso | Texas | 79925 | United States |
| Research Site | Houston | Texas | 77024 | United States |
| Research Site | McKinney | Texas | 75069 | United States |
| Research Site | Round Rock | Texas | 78681 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Bellingham | Washington | 98225 | United States |
| Research Site | Ajax | Ontario | L1S 2J5 | Canada |
| Research Site | Greater Sudbury | Ontario | P3A 1Y8 | Canada |
| Research Site | Greater Sudbury | Ontario | P3A1Y8 | Canada |
| Research Site | Mississauga | Ontario | L5B 1N1 | Canada |
| Research Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| Research Site | Point Edward | Ontario | N7V 1X4 | Canada |
| Research Site | Toronto | Ontario | M5S 2A5 | Canada |
| Research Site | Toronto | Ontario | M6H 3M2 | Canada |
| Research Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| Research Site | St. John's | A1B 4S8 | 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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