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| Sponsor: | SkyePharma AG |
|---|---|
| Information provided by: | SkyePharma AG |
| ClinicalTrials.gov Identifier: | NCT00393952 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Fluticasone propionate/Formoterol fumarate Other: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg or 250/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Placebo or Fluticasone (250 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Moderate to Severe Asthma |
| Enrollment: | 556 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Research Center | |
| Pell City, Alabama, United States, 35128 | |
| United States, Arizona | |
| Research Site | |
| Tucson, Arizona, United States, 85712 | |
| Research Site | |
| Phoenix, Arizona, United States, 85050 | |
| Research Site | |
| Glendale, Arizona, United States, 85306 | |
| Research Center | |
| Phoenix, Arizona, United States, 85050 | |
| United States, Arkansas | |
| Research Site | |
| Jonesboro, Arkansas, United States, 72401 | |
| Research Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Research Site | |
| San Diego, California, United States, 92123 | |
| Research Site | |
| Los Angeles, California, United States, 90025 | |
| Research Site | |
| Monterey Park, California, United States, 91754 | |
| Research Site | |
| San Jose, California, United States, 95128 | |
| Research Site | |
| San Diego, California, United States, 92120 | |
| Research Site | |
| Long Beach, California, United States, 90806 | |
| Research Site | |
| Burbank, California, United States, 91505 | |
| Research Site | |
| Fresno, California, United States, 93720 | |
| Research Site | |
| Mission Viejo, California, United States, 92691 | |
| Research Site | |
| Los Angeles, California, United States, 90048 | |
| Research Site | |
| Palmdale, California, United States, 93551 | |
| Research Site | |
| Sacramento, California, United States, 95819 | |
| Research Center | |
| Los Angeles, California, United States, 90048 | |
| United States, Florida | |
| Research Site | |
| Hialeah, Florida, United States, 33013 | |
| Research Site | |
| Pensacola, Florida, United States, 32503 | |
| Research Site | |
| Tampa, Florida, United States, 33613 | |
| Research Site | |
| Ormond Beach, Florida, United States, 32174 | |
| Research Center | |
| Gainesville, Florida, United States, 32605 | |
| Research Center | |
| Panama City, Florida, United States, 32405 | |
| United States, Georgia | |
| Research Site | |
| Savannah, Georgia, United States, 31406 | |
| Research Center | |
| Congers, Georgia, United States, 30012 | |
| United States, Illinois | |
| Research Site | |
| Round Lake Beach, Illinois, United States, 60073 | |
| United States, Kentucky | |
| Research Site | |
| Louisville, Kentucky, United States, 40215 | |
| United States, Maryland | |
| Research Site | |
| Baltimore, Maryland, United States, 21236 | |
| United States, Massachusetts | |
| Research Site | |
| Taunton, Massachusetts, United States, 02780 | |
| Research Site | |
| N. Dartmouth, Massachusetts, United States, 02747 | |
| United States, Minnesota | |
| Research Site | |
| Plymouth, Minnesota, United States, 55441 | |
| Research Site | |
| Minneapolis, Minnesota, United States, 55402 | |
| Research Center | |
| Minneapolis, Minnesota, United States, 55402 | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, Montana | |
| Research Site | |
| Bozeman, Montana, United States, 59718 | |
| United States, Nebraska | |
| Research Site | |
| Omaha, Nebraska, United States, 68130 | |
| United States, Nevada | |
| Research Site | |
| Las Vegas, Nevada, United States, 89123 | |
| United States, New Jersey | |
| Research Site | |
| Brick, New Jersey, United States, 08724 | |
| Research Site | |
| Mt. Laurel, New Jersey, United States, 08054 | |
| Research Site | |
| Skillman, New Jersey, United States, 08558 | |
| Research Site | |
| Tinton Falls, New Jersey, United States, 07001 | |
| United States, New York | |
| Research Site | |
| Rockville Centre, New York, United States, 11570 | |
| United States, Oklahoma | |
| Research Site | |
| Oklahoma City, Oklahoma, United States, 73139 | |
| United States, Oregon | |
| Research Site | |
| Ashland, Oregon, United States, 97520 | |
| Research Site | |
| Medford, Oregon, United States, 97504 | |
| Research Center | |
| Portland, Oregon, United States, 97213 | |
| United States, Pennsylvania | |
| Research Center | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, Rhode Island | |
| Research Site | |
| Lincoln, Rhode Island, United States, 02865 | |
| United States, South Carolina | |
| Research Site | |
| Greenville, South Carolina, United States, 29607 | |
| Research Center | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Texas | |
| Research Site | |
| San Antonio, Texas, United States, 78229 | |
| Research Site | |
| Dallas, Texas, United States, 75231 | |
| Research Site | |
| Austin, Texas, United States, 78750 | |
| Research Site | |
| El Paso, Texas, United States, 79902 | |
| Research Site | |
| San Antonio, Texas, United States, 72205 | |
| Research Center | |
| Fort Worth, Texas, United States, 76104 | |
| United States, Virginia | |
| Research Site | |
| Richmond, Virginia, United States, 23225 | |
| United States, Washington | |
| Research Site | |
| Tacoma, Washington, United States, 98405 | |
| United States, Wisconsin | |
| Research Site | |
| Milwaukee, Wisconsin, United States, 53209 | |
| Puerto Rico | |
| Research Center | |
| Ponce, Puerto Rico, 00733 | |
More Information
| Study ID Numbers: | SKY2028-3-004 |
| Study First Received: | October 27, 2006 |
| Last Updated: | June 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00393952 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Fluticasone Propionate Formoterol Fumarate |
Pressurized metered dose inhaler Hydrofluoroalkane Moderate-Severe Asthma |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Therapeutic Uses Fluticasone Formoterol |
Dermatologic Agents Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Autonomic Agents Lung Diseases Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |