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| Sponsored by: |
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
Show 41 Study Locations
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 Neurotransmitter Agents Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Anti-Asthmatic Agents Asthma Anti-Allergic Agents Adrenergic Agonists Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate Fluticasone Formoterol Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
|
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 |