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The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 | ||
| time to the first asthma exacerbation. |
| Measure | Description | Time Frame |
|---|---|---|
| FVC | ||
| asthma symptom score | ||
| use of rescue medication |
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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 | Gmünd | 3950 | Austria | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010\_M1-142 Synopsis.pdf | View source |
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| AQLQ(S) and EQ-5D |
| percentage of days on which patients perceived asthma control |
| percentage of nocturnal awakening-free days |
| percentage of rescue medication-free days |
| percentage of asthma symptom-free days |
| physical examination |
| vital signs |
| standard laboratory work-up |
| adverse events |
| number of patients with local oropharyngeal adverse events. |
| Linz |
| 4020 |
| Austria |
| Altana Pharma/Nycomed | Linz | 4040 | Austria |
| Altana Pharma/Nycomed | Neusiedl/See | 7100 | Austria |
| Altana Pharma/Nycomed | Perg | 4320 | Austria |
| Altana Pharma/Nycomed | Steyr | 4400 | Austria |
| Altana Pharma/Nycomed | Wiener Neustadt | 2700 | Austria |
| Altana Pharma/Nycomed | Brandon | R7A 5E7 | Canada |
| Altana Pharma/Nycomed | Hamilton | L8N 3Z5 | Canada |
| Altana Pharma/Nycomed | London | N5W 6A2 | Canada |
| Altana Pharma/Nycomed | London | N6C 4Y7 | Canada |
| Altana Pharma/Nycomed | Mississauga | L5B 1N1 | Canada |
| Altana Pharma/Nycomed | Montreal | H2L 4M1 | Canada |
| Altana Pharma/Nycomed | Montreal | H4J1C5 | Canada |
| Altana Pharma/Nycomed | Montreal, Quebec | H1V 1X5 | Canada |
| Altana Pharma/Nycomed | Ottawa | K1Y 4G2 | Canada |
| Altana Pharma/Nycomed | Québec | G8T 7A1 | Canada |
| Altana Pharma/Nycomed | Sainte-Foy, Quebec | G1V4G5 | Canada |
| Altana Pharma/Nycomed | Sarnia | N7T 4X3 | Canada |
| Altana Pharma/Nycomed | Ste-Foy PQ | G1V 4M6 | Canada |
| Altana Pharma/Nycomed | Toronto | M4P1P2 | Canada |
| Altana Pharma/Nycomed | Woodstock | N4S 4G3 | Canada |
| Altana Pharma/Nycomed | Geesthacht | 21502 | Germany |
| Altana Pharma/Nycomed | Hanover | 30167 | Germany |
| Altana Pharma/Nycomed | Heidelberg | 69117 | Germany |
| Altana Pharma/Nycomed | Koblenz | 56068 | Germany |
| Altana Pharma/Nycomed | Mainz | 55131 | Germany |
| Altana Pharma/Nycomed | Marburg | 35037 | Germany |
| Altana Pharma/Nycomed | Sinsheim | 74889 | Germany |
| Altana Pharma/Nycomed | Witten | 58452 | Germany |
| Altana Pharma/Nycomed | Bielsko-Biala | 43316 | Poland |
| Altana Pharma/Nycomed | Gdansk | 80-847 | Poland |
| Altana Pharma/Nycomed | Lodz | 90-141 | Poland |
| Altana Pharma/Nycomed | Lubin | 59300 | Poland |
| Altana Pharma/Nycomed | Lublin | 20-718 | Poland |
| Altana Pharma/Nycomed | Lublin | 20601 | Poland |
| Altana Pharma/Nycomed | Wałbrzych | 58300 | Poland |
| Altana Pharma/Nycomed | Zgierz | 95100 | Poland |
| Altana Pharma/Nycomed | Arcadia, Pretoria | 132 | South Africa |
| Altana Pharma/Nycomed | Bellville, Cape Town | 7530 | South Africa |
| Altana Pharma/Nycomed | Cape Town | 7764 | South Africa |
| Altana Pharma/Nycomed | Cape Town, Tygerberg | 7505 | South Africa |
| Altana Pharma/Nycomed | Durbanville / Cape Town | 7550 | South Africa |
| Altana Pharma/Nycomed | Gatesville, Cape Town | 7764 | South Africa |
| Altana Pharma/Nycomed | Lyttleton | 140 | South Africa |
| Altana Pharma/Nycomed | Mowbray, Cape Town | 7925 | South Africa |
| Altana Pharma/Nycomed | Observatory Cape | 7925 | South Africa |
| Altana Pharma/Nycomed | Pretoria | 181 | South Africa |
| Altana Pharma/Nycomed | Pretoria | 2 | South Africa |
| Altana Pharma/Nycomed | Westville | 3630 | South Africa |
| Altana Pharma/Nycomed | Wynberg | 7945 | 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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