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The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung function and safety. Ciclesonide will be inhaled at one dose level once daily, using an inhaler device with or without spacer. The study duration consists of a baseline period (1 to 3 weeks) and a treatment period (12 weeks).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1. |
| Measure | Description | Time Frame |
|---|---|---|
| FVC | ||
| morning and evening PEF from diaries | ||
| asthma symptom score |
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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 | La Malbaie, Quebec | G5A 1W7 | Canada | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-MI-145-RDS-2007-05-21.pdf | View source |
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| use of rescue medication |
| number of patients with an asthma exacerbation |
| time to the first asthma exacerbation |
| percentage of days on which patient perceived asthma control |
| percentage of nocturnal awakening-free days |
| percentage of rescue medication-free days |
| percentage of asthma symptom-free days |
| adverse events |
| physical examination |
| vital signs |
| standard laboratory work-up |
| 8 am serum cortisol. |
| London |
| N6A 5R9 |
| Canada |
| Altana Pharma/Nycomed | London,ON | N6A1V2 | Canada |
| Altana Pharma/Nycomed | Mississauga | L5B 1N1 | Canada |
| Altana Pharma/Nycomed | Montreal, Quebec | H1V 1X5 | Canada |
| Altana Pharma/Nycomed | Québec | G8T 7A1 | Canada |
| Altana Pharma/Nycomed | Richmond Hill | L4S 1P3 | Canada |
| Altana Pharma/Nycomed | Sainte-Foy, Quebec | G1V4G5 | Canada |
| Altana Pharma/Nycomed | Saskatoon,SK | S7H 0W2 | Canada |
| Altana Pharma/Nycomed | Scarborough,ON | M1B 4Z8 | Canada |
| Altana Pharma/Nycomed | Toronto | M4P1P2 | Canada |
| Altana Pharma/Nycomed | Vancouver, BC | V5Z 4E1 | Canada |
| Altana Pharma/Nycomed | Winnipeg | R2M 5L9 | Canada |
| Altana Pharma/Nycomed | Winnipeg MB | R3C 0N2 | Canada |
| Altana Pharma/Nycomed | Woodstock | N4S 4G3 | Canada |
| Altana Pharma/Nycomed | Aix-en-Provence | 13090 | France |
| Altana Pharma/Nycomed | Chauny | 2303 | France |
| Altana Pharma/Nycomed | Ferolles-Attily | 77150 | France |
| Altana Pharma/Nycomed | Grasse | 6130 | France |
| Altana Pharma/Nycomed | La Rochelle | 17000 | France |
| Altana Pharma/Nycomed | La Teste-de-Buch | 33260 | France |
| Altana Pharma/Nycomed | Libourne | 33500 | France |
| Altana Pharma/Nycomed | Lille | 59000 | France |
| Altana Pharma/Nycomed | Martigues | 13695 | France |
| Altana Pharma/Nycomed | Montbrison | 42600 | France |
| Altana Pharma/Nycomed | Montpellier | 34070 | France |
| Altana Pharma/Nycomed | Nice | 6000 | France |
| Altana Pharma/Nycomed | Nîmes | 30900 | France |
| Altana Pharma/Nycomed | Saint-Laurent-du-Var | 6700 | France |
| Altana Pharma/Nycomed | Saint-Quentin | 2100 | France |
| Altana Pharma/Nycomed | Berlin | 10717 | Germany |
| Altana Pharma/Nycomed | Berlin | 13597 | Germany |
| Altana Pharma/Nycomed | Oschersleben | 39387 | Germany |
| Altana Pharma/Nycomed | Rüdersdorf | 15562 | Germany |
| Altana Pharma/Nycomed | Schwetzingen | 68723 | Germany |
| Altana Pharma/Nycomed | Weinheim | 69469 | Germany |
| Altana Pharma/Nycomed | Balassagyarmat | 2660 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1121 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1134 | Hungary |
| Altana Pharma/Nycomed | Budapet | 1529 | Hungary |
| Altana Pharma/Nycomed | Érd | 2030 | Hungary |
| Altana Pharma/Nycomed | Gyula | 5703 | Hungary |
| Altana Pharma/Nycomed | Komárom | 2900 | Hungary |
| Altana Pharma/Nycomed | Miskolc | 3501 | Hungary |
| Altana Pharma/Nycomed | Mosdós | 7257 | Hungary |
| Altana Pharma/Nycomed | Nyiregyháza | 4412 | Hungary |
| Altana Pharma/Nycomed | Pécs | 7621 | Hungary |
| Altana Pharma/Nycomed | Szeged | 6722 | Hungary |
| Altana Pharma/Nycomed | Székesfehérvár | 8000 | Hungary |
| Altana Pharma/Nycomed | Bangalore | 560 034 | India |
| Altana Pharma/Nycomed | Chennai | 600 034 | India |
| Altana Pharma/Nycomed | Coimbatore | 641 014 | India |
| Altana Pharma/Nycomed | Coimbatore | 641004 | India |
| Altana Pharma/Nycomed | Coimbatore, Tamilnadu | 641 044 | India |
| Altana Pharma/Nycomed | Goā | 403 002 | India |
| Altana Pharma/Nycomed | Kalaburagi | 585105 | India |
| Altana Pharma/Nycomed | Mumbai | 400008 | India |
| Altana Pharma/Nycomed | Mumbai, Dadar (E) | 400 014 | India |
| Altana Pharma/Nycomed | Pune | India |
| Altana Pharma/Nycomed | Florence | 50134 | Italy |
| Altana Pharma/Nycomed | Milan | 20122 | Italy |
| Altana Pharma/Nycomed | Milan | 20142 | Italy |
| Altana Pharma/Nycomed | Milan | 20153 | Italy |
| Altana Pharma/Nycomed | Naples | 80131 | Italy |
| Altana Pharma/Nycomed | Pordenone | 33170 | Italy |
| Altana Pharma/Nycomed | Verona | 30012 | Italy |
| 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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