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This trial will compare the effectiveness of one dose of ciclesonide against one dose of budesonide in patients with asthma.
The aim of the present trial is to compare the efficacy of ciclesonide versus budesonide on pulmonary function, symptoms and use of rescue medication in patients with asthma. The onset of action and the safety and tolerability of ciclesonide in comparison to budesonide will also be investigated.
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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 | Busan | 602-715 | South Korea | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-M1-136-RDS-2006-12-03.pdf | View source |
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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). |
| Daegu |
| 700-712 |
| South Korea |
| Altana Pharma/Nycomed | Daegu | 700-721 | South Korea |
| Altana Pharma/Nycomed | Daejeon | 301-721 | South Korea |
| Altana Pharma/Nycomed | Gangwon-do | 220-701 | South Korea |
| Altana Pharma/Nycomed | Gwangju | 501-757 | South Korea |
| Altana Pharma/Nycomed | Gyeonggi-do | 420-767 | South Korea |
| Altana Pharma/Nycomed | Gyeonggi-do | 442-721 | South Korea |
| Altana Pharma/Nycomed | Jeonju | 561-712 | South Korea |
| Altana Pharma/Nycomed | Jungnam | 330-715 | South Korea |
| Altana Pharma/Nycomed | Seoul | 120-749 | South Korea |
| Altana Pharma/Nycomed | Seoul | 133-792 | South Korea |
| Altana Pharma/Nycomed | Seoul | 134-701 | South Korea |
| Altana Pharma/Nycomed | Seoul | 135-710 | South Korea |
| Altana Pharma/Nycomed | Seoul | 137-701 | South Korea |
| Altana Pharma/Nycomed | Seoul | 138-736 | South Korea |
| Altana Pharma/Nycomed | Seoul | 140-757 | South Korea |
| Altana Pharma/Nycomed | Seoul | 158-710 | South Korea |
| Altana Pharma/Nycomed | Taebuk | 361-711 | South Korea |
| 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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