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The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 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 |
|---|---|---|
| variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh | ||
| FVC% at PC20 AMP, SVC% at PC20 AMP | ||
| regional air trapping | ||
| bronchial and alveolar exhaled NO | ||
| lung function variables | ||
| non-cellular inflammatory markers. |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability. |
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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 | RB Groningen | 9700 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18287130 | Derived | Cohen J, Douma WR, ten Hacken NH, Vonk JM, Oudkerk M, Postma DS. Ciclesonide improves measures of small airway involvement in asthma. Eur Respir J. 2008 Jun;31(6):1213-20. doi: 10.1183/09031936.00082407. Epub 2008 Feb 20. |
| Label | URL |
|---|---|
| BY9010\_M1-131 Synopsis | 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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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |