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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone propionate/formoterol fumarate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety after twice daily treatment with FlutiForm HFA MDI over 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term efficacy after twice daily treatment with FlutiForm HFA MDI over 12 months. |
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Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring.
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23098325 | Derived | Mansur AH, Kaiser K. Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma. J Aerosol Med Pulm Drug Deliv. 2013 Aug;26(4):190-9. doi: 10.1089/jamp.2012.0977. Epub 2012 Oct 25. |
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| Hamburg |
| Germany |
| Research Site | Mainz | Germany |
| Research Site | Rüdersdorf | Germany |
| Research Site | Solingen | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Deszk | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Miskolc | Hungary |
| Research Site | Mosonmagyaróvár | Hungary |
| Research Site | Bialystok | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lodz | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Bucharest | Romania |
| Research Site | Birmingham | United Kingdom |
| Research Site | Carrickfergus | United Kingdom |
| Research Site | Chippenham | United Kingdom |
| Research Site | Cottingham | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Downpatrick | United Kingdom |
| Research Site | Heywood | United Kingdom |
| Research Site | Manchester | United Kingdom |
| Research Site | Sheffield | United Kingdom |
| Research Site | Solihull | United Kingdom |
| Research Site | Sunbury-on-Thames | United Kingdom |
| Research Site | Swindon Wilts | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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