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Sponsored by: |
SkyePharma AG |
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 |
Asthma |
Drug: Fluticasone propionate/formoterol fumarate |
Phase III |
MedlinePlus related topics: | Asthma |
ChemIDplus related topics: | Fluticasone propionate Fluticasone Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate HFA 227 |
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 | |||||
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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 | |||||
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Carrickfergus, United Kingdom |
SkyePharma AG |
Study ID Numbers: | SKY2028-3-003 |
First Received: | October 27, 2006 |
Last Updated: | May 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00394121 |
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 |
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