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The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 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 % of predicted | ||
| PEF from spirometry | ||
| diary based morning and evening PEF |
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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 | Ahmedabad | 380 018 | India | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010\_M1-205 Synopsis | View source |
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| diary based symptom score |
| diary based salbutamol MDI use |
| diurnal PEF fluctuation |
| drop-out rate due to asthma exacerbations |
| time until asthma exacerbation |
| number of symptom free- and rescue medication free days |
| number of days with asthma control |
| physical examination |
| vital signs |
| laboratory work-up |
| adverse events. |
| Bangalore |
| 560 034 |
| India |
| Altana Pharma/Nycomed | Chandigarh | 160 012 | India |
| Altana Pharma/Nycomed | Coimbatore | 641 004 | India |
| Altana Pharma/Nycomed | Coimbatore | 641 014 | India |
| Altana Pharma/Nycomed | Coimbatore, Tamilnadu | 641 044 | India |
| Altana Pharma/Nycomed | Delhi | 110 007 | India |
| Altana Pharma/Nycomed | Kolkata | 700091 | India |
| Altana Pharma/Nycomed | Mumbai | 400 004 | India |
| Altana Pharma/Nycomed | Mumbai | 400 012 | India |
| Altana Pharma/Nycomed | Mumbai | 400 022 | India |
| Altana Pharma/Nycomed | Mumbai | 400 026 | India |
| Altana Pharma/Nycomed | Pune | 411 001 | India |
| Altana Pharma/Nycomed | Pune | 411 030 | India |
| Altana Pharma/Nycomed | Pune | 411 033 | India |
| Altana Pharma/Nycomed | Shastri Nagar, Jaipur | 302 016 | India |
| 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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