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| Sponsor: | SkyePharma AG |
|---|---|
| Information provided by: | SkyePharma AG |
| ClinicalTrials.gov Identifier: | NCT00394199 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Fluticasone propionate/Formoterol Fumarate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Active-Controlled, Parallel Group, Stratified, Multi-Center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma |
| Estimated Enrollment: | 350 |
| Study Start Date: | June 2006 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 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 |
Inclusion Criteria:
Exclusion Criteria:
Patients will not be eligible for the study if they meet any of the following criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Research Site | |
| Birmingham, Alabama, United States, 35242 | |
| United States, California | |
| Research Site | |
| Orange, California, United States, 92868 | |
| Research Site | |
| San Jose, California, United States, 95117 | |
| Research Site | |
| Vista, California, United States, 92083 | |
| Research Site | |
| Mission Viejo, California, United States, 92691 | |
| United States, Colorado | |
| Research Site | |
| Denver, Colorado, United States, 80230 | |
| United States, Georgia | |
| Research Site | |
| Lilburn, Georgia, United States, 30047 | |
| Research Site | |
| Savannah, Georgia, United States, 31406 | |
| United States, Kansas | |
| Research Site | |
| Park City, Kansas, United States, 67219 | |
| United States, Maryland | |
| Research Site | |
| Bethesda, Maryland, United States, 20814 | |
| United States, Massachusetts | |
| Research Site | |
| N. Dartmouth, Massachusetts, United States, 02747 | |
| United States, Michigan | |
| Research Center | |
| Stevensville, Michigan, United States, 49127 | |
| United States, New Jersey | |
| Research Site | |
| Elizabeth, New Jersey, United States, 07202 | |
| United States, New York | |
| Research Center | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Research Site | |
| Asheville, North Carolina, United States, 28801 | |
| Research Site | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, Ohio | |
| Research Site | |
| Cincinnati, Ohio, United States, 45242 | |
| Research Site | |
| Sylvania, Ohio, United States, 43560 | |
| United States, Pennsylvania | |
| Research Site | |
| Easton, Pennsylvania, United States, 18045 | |
| United States, Rhode Island | |
| Research Site | |
| Lincoln, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Research Site | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Tennessee | |
| Research Site | |
| Chattanooga, Tennessee, United States, 37421 | |
| United States, Texas | |
| Research Site | |
| Katy, Texas, United States, 77450 | |
| Research Site | |
| Waco, Texas, United States, 76712 | |
| Research Site | |
| New Braunfels, Texas, United States, 78130 | |
| Research Site | |
| El Paso, Texas, United States, 79902 | |
| Research Site | |
| Houston, Texas, United States, 77054 | |
| United States, Vermont | |
| Research Site | |
| South Burlington, Vermont, United States, 05403 | |
| United States, Wisconsin | |
| Research Site | |
| Greenfield, Wisconsin, United States, 53228 | |
| Canada, British Columbia | |
| Research Site | |
| Vancouver, British Columbia, Canada, V5Z 3J5 | |
| Research Site | |
| Kelowna, British Columbia, Canada, V1Y 9L8 | |
| Canada, Ontario | |
| Research Site | |
| Hamilton, Ontario, Canada, L8N 1Y2 | |
| Research Site | |
| Toronto, Ontario, Canada, M4P 1P2 | |
| Research Site | |
| London, Ontario, Canada, N6A 1V2 | |
| Research Site | |
| Mississauga, Ontario, Canada, L4W 1N2 | |
| Research Site | |
| Oshawa, Ontario, Canada, L1H 1B9 | |
| Research Center | |
| London, Ontario, Canada, N5X 4E7 | |
| Canada, Quebec | |
| Research Site | |
| Longueuil, Quebec, Canada, J4N 1E1 | |
| Research Site | |
| Trois Rivieres, Quebec, Canada, G8T 7A1 | |
| Research Site | |
| Saint Foy, Quebec, Canada, G1V 4M6 | |
| Research Site | |
| Montreal, Quebec, Canada, H2L 2W5 | |
More Information
| Study ID Numbers: | SKY2028-3-002 |
| Study First Received: | October 27, 2006 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00394199 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Asthma Fluticasone Propionate formoterol fumarate |
Pressurized metered dose inhaler Hydrofluoroalkane Mild to Moderate 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 |