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 this study is to compare the efficacy and safety of the fixed combination asthma drug FlutiForm with its two components administered alone, fluticasone propionate and formoterol fumarate, and with placebo in adult and adolescent patients with moderate to severe asthma.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | FlutiForm 250/10 |
|
| 2 | Active Comparator | FlutiForm 100/10 |
|
| 3 | Active Comparator | Fluticasone 250 |
|
| 4 | Active Comparator | Formoterol 10 |
|
| 5 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate/Formoterol fumarate 250/10 | Drug | FlutiForm 250/10ug is a HFA pMDI that delivers 125ug 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 Baseline (Week 0) to Week 12. | Week 0 and 12 visits | |
| Discontinuation due to lack of efficacy. | Whole duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Other pulmonary function tests including forced vial 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). |
Not provided
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Pell City | Alabama | 35128 | United States | ||
| Research Site |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks. |
|
|
| 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. |
|
|
| Fluticasone propionate 250 | Drug | Fluticasone 250 is a HFA pMDI that delivers 125ug 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 |
| Serial 12-hour FEV-1 area under the curve (AUC). | Week 0, 2 and 12 visits |
| Safety variables including adverse events, ECGs clinical laboratory tests and vital signs. | Whole duration of study |
| Glendale |
| Arizona |
| 85306 |
| United States |
| Research Center | Phoenix | Arizona | 85050 | United States |
| Research Site | Phoenix | Arizona | 85050 | United States |
| Research Site | Tucson | Arizona | 85712 | United States |
| Research Site | Jonesboro | Arkansas | 72401 | United States |
| Research Site | Little Rock | Arkansas | 72205 | United States |
| Research Site | Burbank | California | 91505 | United States |
| Research Site | Fresno | California | 93720 | United States |
| Research Site | Long Beach | California | 90806 | United States |
| Research Site | Los Angeles | California | 90025 | United States |
| Research Center | Los Angeles | California | 90048 | United States |
| Research Site | Los Angeles | California | 90048 | United States |
| Research Site | Mission Viejo | California | 92691 | United States |
| Research Site | Monterey Park | California | 91754 | United States |
| Research Site | Palmdale | California | 93551 | United States |
| Research Site | Sacramento | California | 95819 | United States |
| Research Site | San Diego | California | 92120 | United States |
| Research Site | San Diego | California | 92123 | United States |
| Research Site | San Jose | California | 95128 | United States |
| Research Center | Gainesville | Florida | 32605 | United States |
| Research Site | Hialeah | Florida | 33013 | United States |
| Research Site | Ormond Beach | Florida | 32174 | United States |
| Research Center | Panama City | Florida | 32405 | United States |
| Research Site | Pensacola | Florida | 32503 | United States |
| Research Site | Tampa | Florida | 33613 | United States |
| Research Center | Congers | Georgia | 30012 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Round Lake Beach | Illinois | 60073 | United States |
| Research Site | Louisville | Kentucky | 40215 | United States |
| Research Site | Baltimore | Maryland | 21236 | United States |
| Research Site | North Dartmouth | Massachusetts | 02747 | United States |
| Research Site | Taunton | Massachusetts | 02780 | United States |
| Research Center | Minneapolis | Minnesota | 55402 | United States |
| Research Site | Minneapolis | Minnesota | 55402 | United States |
| Research Site | Plymouth | Minnesota | 55441 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Bozeman | Montana | 59718 | United States |
| Research Site | Omaha | Nebraska | 68130 | United States |
| Research Site | Las Vegas | Nevada | 89123 | United States |
| Research Site | Brick | New Jersey | 08724 | United States |
| Research Site | Mount Laurel | New Jersey | 08054 | United States |
| Research Site | Skillman | New Jersey | 08558 | United States |
| Research Site | Tinton Falls | New Jersey | 07001 | United States |
| Research Site | Rockville Centre | New York | 11570 | United States |
| Research Site | Oklahoma City | Oklahoma | 73139 | United States |
| Research Site | Ashland | Oregon | 97520 | United States |
| Research Site | Medford | Oregon | 97504 | United States |
| Research Center | Portland | Oregon | 97213 | United States |
| Research Center | Upland | Pennsylvania | 19013 | United States |
| Research Site | Lincoln | Rhode Island | 02865 | United States |
| Research Center | Anderson | South Carolina | 29621 | United States |
| Research Site | Greenville | South Carolina | 29607 | United States |
| Research Site | Austin | Texas | 78750 | United States |
| Research Site | Dallas | Texas | 75231 | United States |
| Research Site | El Paso | Texas | 79902 | United States |
| Research Center | Fort Worth | Texas | 76104 | United States |
| Research Site | San Antonio | Texas | 72205 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Richmond | Virginia | 23225 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| Research Site | Milwaukee | Wisconsin | 53209 | United States |
| Research Center | Ponce | 00733 | Puerto Rico |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided