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Sponsored by: |
SkyePharma AG |
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Information provided by: | SkyePharma AG |
ClinicalTrials.gov Identifier: | NCT00394121 |
The purpose of this study is to evaluate the long-term safety of the fixed combination asthma drug FlutiForm HFA MDI (containing fluticasone propionate and formoterol fumarate) in adult and adolescent patients with mild to moderate-severe asthma.
Condition | Intervention | Phase |
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Asthma |
Drug: Fluticasone propionate/formoterol fumarate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | Long-Term Open-Label Safety Study With SkyePharma FlutiForm HFA pMDI (100/10 µg and 250/10 µg) in Adult and Adolescent Patients With Asthma |
Estimated Enrollment: | 400 |
Study Start Date: | March 2006 |
Study Completion Date: | February 2008 |
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:
Germany | |
Research Site | |
Hamburg, Germany | |
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Berlin, Germany | |
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Mainz, Germany | |
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Rudersdorf, Germany | |
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Solingen, Germany | |
Hungary | |
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Deszk, Hungary | |
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Miskolc, Hungary | |
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Mosonmagyarovar, Hungary | |
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Kecskemet, Hungary | |
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Budapest, Hungary | |
Poland | |
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Bialystok, Poland | |
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Krakow, Poland | |
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Gdansk, Poland | |
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Lodz, Poland | |
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Wroclaw, Poland | |
Romania | |
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Bucharest, Romania | |
United Kingdom | |
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Birmingham, United Kingdom | |
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Solihull, United Kingdom | |
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Downpatrick, United Kingdom | |
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Swindon Wilts, United Kingdom | |
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Coventry, United Kingdom | |
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Cottingham, United Kingdom | |
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Heywood, United Kingdom | |
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Sheffield, United Kingdom | |
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Chippenham, United Kingdom | |
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Manchester, United Kingdom | |
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Sunbury on Thames, United Kingdom | |
Research Site | |
Carrickfergus, United Kingdom |
Study ID Numbers: | SKY2028-3-003 |
Study First Received: | October 27, 2006 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00394121 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Romania: National Medicines Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Asthma Fluticasone Propionate Formoterol Fumarate |
Pressurized metered does inhaler Hydrofluoroalkane Mild to moderate-severe 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 |