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To investigate the efficacy and safety of ciclesonide inhaled into the lungs in a range of doses in a new dry powder inhaler compared to ciclesonide inhaled into the lungs using a metered dose inhaler
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVE2635A | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Primary endpoint will be the change from baseline to week 6 in FEV1 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters measured after 4 weeks of treatment. Change from baseline in serum cortisol pre-and post ACTH stimulation, AM and PM peak expiratory flow rates, AM and PM asthma symptoms, and albuterol use after 6 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001986 | Bronchial Spasm |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |