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The aim of the study is to compare the efficacy of two doses of a fixed combination of ciclesonide/formoterol fumarate versus ciclesonide alone versus formoterol fumarate alone in patients with asthma. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (8 weeks). The study will provide further data on safety and tolerability of ciclesonide/formoterol fumarate.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide/Formoterol Combination | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the first experience of lack of efficacy | ||
| AUC (FEV1) over a 24 h dosing interval. |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | ||
| morning and evening PEF, asthma symptoms and use of rescue medication | ||
| proportion of patients with a clinical asthma exacerbation. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altana Pharma/Nycomed | Grenoble | 38100 | France | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010 M1-506.pdf | View source |
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| Montpellier |
| 34295 |
| France |
| Altana Pharma/Nycomed | Berlin | 14050 | Germany |
| Altana Pharma/Nycomed | Großhansdorf | 22927 | Germany |
| Altana Pharma/Nycomed | Mainz | 55131 | Germany |
| Altana Pharma/Nycomed | Rüdersdorf | 15562 | Germany |
| Altana Pharma/Nycomed | Wiesbaden | 65187 | Germany |
| Altana Pharma/Nycomed | Balassagyarmat | 2660 | Hungary |
| Altana Pharma/Nycomed | Balatonfüred | 8230 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1125 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1529 | Hungary |
| Altana Pharma/Nycomed | Csorna | 9300 | Hungary |
| Altana Pharma/Nycomed | Debrecen | 4043 | Hungary |
| Altana Pharma/Nycomed | Győr | 9024 | Hungary |
| Altana Pharma/Nycomed | Mátraháza | 3233 | Hungary |
| Altana Pharma/Nycomed | Mosonmagyaróvár | 9200 | Hungary |
| Altana Pharma/Nycomed | Nyíregyháza | 4400 | Hungary |
| Altana Pharma/Nycomed | Szolnok | 5006 | Hungary |
| Altana Pharma/Nycomed | Szombathely | 9700 | Hungary |
| Altana Pharma/Nycomed | Arcadia, Pretoria | 132 | South Africa |
| Altana Pharma/Nycomed | Bellville, Cape Town | 7530 | South Africa |
| Altana Pharma/Nycomed | Bloemfontein | 9300 | South Africa |
| Altana Pharma/Nycomed | Cape Town, Tygerberg | 7505 | South Africa |
| Altana Pharma/Nycomed | Mowbray, Cape Town | 7925 | South Africa |
| Altana Pharma/Nycomed | Panorama / RSA-Cape Town | 7500 | South Africa |
| Altana Pharma/Nycomed | Pretoria | South Africa |
| 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 |
|---|---|
| C120481 | ciclesonide |
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