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The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 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 |
|---|---|---|
| AUC(0-24h)/24 h of serum cortisol level | ||
| 24 h urinary cortisol excretion adjusted for creatinine. |
| Measure | Description | Time Frame |
|---|---|---|
| 8 am measurement of bone formation markers | ||
| PC20FEV1 to methacholine | ||
| PC20FEV1 to AMP |
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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 | Genk | 3600 | Belgium | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-MI-129-RDS-2007-04-25.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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| lung function (FEV1, FVC) |
| pharmacokinetics |
| safety and tolerability. |
| Ghent |
| 9000 |
| Belgium |
| Altana Pharma/Nycomed | Lanaken | 3620 | Belgium |
| Altana Pharma/Nycomed | Liège | 4000 | Belgium |
| Altana Pharma/Nycomed | Liége | 4000 | Belgium |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |