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The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 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 absolute values. |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 as percent of predicted | ||
| FVC | ||
| PEF absolute values |
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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 | Kota Bharu / Kelantan | 16150 | Malaysia | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-M1-137-RDS-2006-12-03.pdf | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C120481 | ciclesonide |
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| morning and evening PEF from diary |
| diurnal PEF fluctuation |
| asthma symptom score from diary |
| use of rescue medication from diary |
| number of symptom free- and rescue medication free days |
| dropout rate due to asthma exacerbations |
| time until first asthma exacerbation |
| number of days with asthma control |
| onset of effect |
| subgroup analysis for ex/current smokers and non-smokers |
| AQLQ(S) |
| physical examination |
| vital signs |
| laboratory work-up |
| adverse events. |
| Kuala Lumpur |
| 50586 |
| Malaysia |
| Altana Pharma/Nycomed | Kuala Lumpur | 50603 | Malaysia |
| Altana Pharma/Nycomed | Kuala Lumpur | 56000 | Malaysia |
| Altana Pharma/Nycomed | Taipei | 886-114 | Taiwan |
| Altana Pharma/Nycomed | Taipei | Taiwan |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |