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Sponsored by: |
SkyePharma AG |
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Information provided by: | SkyePharma AG |
ClinicalTrials.gov Identifier: | NCT00393952 |
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) |
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:
Study ID Numbers: | SKY2028-3-004 |
Study First Received: | October 27, 2006 |
Last Updated: | June 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00393952 |
Health Authority: | United States: Food and Drug Administration |
Asthma Fluticasone Propionate Formoterol Fumarate |
Pressurized metered dose inhaler Hydrofluoroalkane Moderate-Severe Asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Hypersensitivity, Immediate |
Formoterol Fluticasone Asthma Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Diseases Immune System Diseases Adrenergic beta-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
Anti-Asthmatic Agents Anti-Allergic Agents Adrenergic Agonists Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents |