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The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclesonide 160µg |
|
| 2 | Active Comparator | Ciclesonide 320µg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | Effect of Ciclesonide on Quality of Life |
|
| Measure | Description | Time Frame |
|---|---|---|
| differences in Quality of Life from AQLQ(S) (T end versus T0) | 8 weeks | |
| time to first exacerbation | 8 weeks | |
| differences in FEV1 and FVC from spirometry (T end vs T0). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of days on which patients perceived asthma control | 8 weeks | |
| percentage of asthma symptoms free days | 8 weeks | |
| percentage of rescue medication-free days |
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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 | Buenos Aires | B1902CSK | Argentina | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-AR-101-RDS-2009-06-19.pdf | View source |
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| 8 weeks |
| percentage of nocturnal awakening-free days | 8 weeks |
| asthma symptom score (daytime score, nighttime score, total score) | 8 weeks |
| use of rescue medication | 8 weeks |
| PEF from spirometry | 8 weeks |
| morning and evening PEF from diary | 8 weeks |
| diurnal PEF fluctuation. | 8 weeks |
| Buenos Aires |
| B7540GHQ |
| Argentina |
| Altana Pharma/Nycomed | Buenos Aires | B8000AAT | Argentina |
| Altana Pharma/Nycomed | Cap. Fed. | C1117ABE | Argentina |
| Altana Pharma/Nycomed | Cap. Fed. | C1121ABE | Argentina |
| Altana Pharma/Nycomed | Cap. Fed. | C1221ADC | Argentina |
| Altana Pharma/Nycomed | Cap. Fed. | C1427ARN | Argentina |
| Altana Pharma/Nycomed | Córdoba | X5000BFB | Argentina |
| Altana Pharma/Nycomed | Córdoba | X5016KEH | Argentina |
| Altana Pharma/Nycomed | Mendoza | M5500CCG | Argentina |
| Altana Pharma/Nycomed | San Miguel de Tucumán | T4146DAL | Argentina |
| Altana Pharma/Nycomed | Santa Fe | S2000DSV | Argentina |
| 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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