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| ID | Type | Description | Link |
|---|---|---|---|
| EurodraCT No. 2004-004905-11 | |||
| AHEAD |
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The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol Turbuhaler | Drug |
| ||
| Salmeterol/fluticasone Diskus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first severe asthma exacerbation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of severe asthma exacerbations | ||
| Mild asthma exacerbations | ||
| FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion and exclusion criteria will be evaluated by the Investigator.
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Symbicort Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Mar del Plata | Buenos Aires | Argentina | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22932169 | Derived | Lin JT, Chen P, Zhou X, Sun TY, Xie CM, Xiu QY, Yao WZ, Yang L, Yin KS, Zhang YM. Budesonide/formoterol maintenance and reliever therapy in Chinese patients with asthma. Chin Med J (Engl). 2012 Sep;125(17):2994-3001. | |
| 17905575 | Derived | Bousquet J, Boulet LP, Peters MJ, Magnussen H, Quiralte J, Martinez-Aguilar NE, Carlsheimer A. Budesonide/formoterol for maintenance and relief in uncontrolled asthma vs. high-dose salmeterol/fluticasone. Respir Med. 2007 Dec;101(12):2437-46. doi: 10.1016/j.rmed.2007.07.014. Epub 2007 Oct 1. |
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| Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries |
| Healthcare utilization |
| Safety (adverse events) |
| - all variables assessed over the 6 months treatment period |
| Monte Grande |
| Buenos Aires |
| Argentina |
| Research Site | Córdoba | Córdoba Province | Argentina |
| Research Site | Santa Fe | Santa Fe Province | Argentina |
| Research Site | San Miguel de Tucumán | Tucumán Province | Argentina |
| Research Site | Buenos Aires | Argentina |
| Research Site | San Miguel de Tucumán | Argentina |
| Research Site | Bankstown | New South Wales | Australia |
| Research Site | Sydney | New South Wales | Australia |
| Research Site | Westmead | New South Wales | Australia |
| Research Site | Bundaberg | Queensland | Australia |
| Research Site | Carina Heights | Queensland | Australia |
| Research Site | Mackay | Queensland | Australia |
| Research Site | Ashford | South Australia | Australia |
| Research Site | Toorak Gardens | South Australia | Australia |
| Research Site | Woodville South | South Australia | Australia |
| Research Site | Box Hill | Victoria | Australia |
| Research Site | Malvern | Victoria | Australia |
| Research Site | Prahran | Victoria | Australia |
| Research Site | Rosebud | Victoria | Australia |
| Research Site | Nedlands | Western Australia | Australia |
| Research Site | Salvador | Estado de Bahia | Brazil |
| Research Site | Juiz de Fora | Minas Gerais | Brazil |
| Research Site | Recife | Pernambuco | Brazil |
| Research Site | Rio de Janeiro | Rio de Janeiro | Brazil |
| Research Site | Florianópolis | Santa Catarina | Brazil |
| Research Site | São Paulo | São Paulo | Brazil |
| Research Site | Curitiba | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Mount Pearl | Newfoundland and Labrador | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | North York | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| Research Site | Saint-Léonard | Quebec | Canada |
| Research Site | Ste-Foy | Quebec | Canada |
| Research Site | Trois-Rivières | Quebec | Canada |
| Research Site | Saskatoon | Saskatchewan | Canada |
| Research Site | Beijing | China |
| Research Site | Guangzhou | China |
| Research Site | Nanjin | China |
| Research Site | Shanghai | China |
| Research Site | Shanxi | China |
| Research Site | Shenyang | China |
| Research Site | Angers | France |
| Research Site | Bernay | France |
| Research Site | Béthune | France |
| Research Site | Chamalières | France |
| Research Site | Férolles-Attilly | France |
| Research Site | Grasse | France |
| Research Site | Hénin-Beaumont | France |
| Research Site | La Rochelle | France |
| Research Site | Laon | France |
| Research Site | Le Havre | France |
| Research Site | Lille | France |
| Research Site | Lorient | France |
| Research Site | Marseille | France |
| Research Site | Montereau-Fault-Yonne | France |
| Research Site | Montpellier | France |
| Research Site | Nantes | France |
| Research Site | Nîmes | France |
| Research Site | Paris | France |
| Research Site | Saint-Denis | France |
| Research Site | Saint-Laurent-du-Var | France |
| Research Site | Sélestat | France |
| Research Site | Toulouse | France |
| Research Site | Villebon-sur-Yvette | France |
| Research Site | Villejuif | France |
| Research Site | Cottbus | Brandenburg | Germany |
| Research Site | Hamburg | Free and Hanseatic City of Hamburg | Germany |
| Research Site | Frankfurt am Main | Hesse | Germany |
| Research Site | Düsseldorf | North Rhine-Westphalia | Germany |
| Research Site | Münster | North Rhine-Westphalia | Germany |
| Research Site | Bad Segeberg | Schleswig-Holstein | Germany |
| Research Site | Berlin | State of Berlin | Germany |
| Research Site | Jena-Maua | Thuringia | Germany |
| Research Site | Bonn | Germany |
| Research Site | Düsseldorf | Germany |
| Research Site | Erfurt | Germany |
| Research Site | Geesthacht | Germany |
| Research Site | Großhansdorf | Germany |
| Research Site | Hagen | Germany |
| Research Site | Kassel | Germany |
| Research Site | Koblenz | Germany |
| Research Site | Lübeck | Germany |
| Research Site | Marburg | Germany |
| Research Site | Neuruppin | Germany |
| Research Site | Sonneberg | Germany |
| Research Site | Witten | Germany |
| Research Site | Coimbatore | India |
| Research Site | Hyderbad | India |
| Research Site | Mumbai | India |
| Research Site | Noida | India |
| Research Site | Semarang | Central Java | Indonesia |
| Research Site | Jakarta Timur | Jakarta - Indonesia | Indonesia |
| Research Site | Bandung | Indonesia |
| Research Site | Jakarta | Indonesia |
| Research Site | Jakarta Timur | Indonesia |
| Research Site | Solo | Indonesia |
| Research Site | Kuala Lumpur | Malaysia |
| Research Site | Seremban | Malaysia |
| Research Site | Zapopan | Jalisco | Mexico |
| Research Site | Villahermosa | Tabasco | Mexico |
| Research Site | México | Mexico |
| Research Site | Cebu City | Philippines |
| Research Site | Iloilo City | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Singapore | Singapore |
| Research Site | Bryanston | Gauteng | South Africa |
| Research Site | Florida Park | Gauteng | South Africa |
| Research Site | Lenasia | Gauteng | South Africa |
| Research Site | Linksfield | Gauteng | South Africa |
| Research Site | Sandton | Gauteng | South Africa |
| Research Site | Witbank | Gauteng | South Africa |
| Research Site | Hillcrest | Pretoria | South Africa |
| Research Site | Bellville | South Africa |
| Research Site | Bloemfontein | South Africa |
| Research Site | Cape Town | South Africa |
| Research Site | Durban | South Africa |
| Research Site | eMkhomazi | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Lyttelton Manor | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Barcelona | Barcelona | Spain |
| Research Site | Santander | Cantabria | Spain |
| Research Site | Granada | Granada | Spain |
| Research Site | San Sebastián | Guipuzcoa | Spain |
| Research Site | Jaén | Jaén | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | El Palmar | Murcia | Spain |
| Research Site | Seville | Sevilla | Spain |
| Research Site | Vitoria-Gasteiz | Vitoria | Spain |
| Research Site | Zaragoza | Zaragoza | Spain |
| Research Site | Seville | Spain |
| Research Site | Bangkok | Thailand |
| Research Site | Khon Kaen | Thailand |
| Research Site | Ho Chi Minh City | Vietnam |
| 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 |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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