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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 once daily, using one of the two dose levels; 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 | ||
| PD20FEV1 from methacholine challenge. |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 as % of predicted | ||
| PEF from spirometry | ||
| morning and evening PEF from diary |
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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 | Campinas - SP | 13081970 | Brazil | |||
| Altana Pharma/Nycomed |
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| Label | URL |
|---|---|
| BY9010-MI-206-RDS-2006-09-01.pdf | View source |
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| asthma symptom score from diary |
| salbutamol MDI use from diary |
| diurnal PEF fluctuation from diary |
| dropout rate due to asthma exacerbations and time to the first asthma exacerbation |
| percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control |
| onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication |
| interview administered PAQLQ(S), self-administered PACQLQ |
| physical examination and vital signs |
| laboratory investigation |
| AEs |
| HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples. |
| Curitiba-PR |
| 80060900 |
| Brazil |
| Altana Pharma/Nycomed | Florianópolis-SC | 88040970 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre-RS | 90035003 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre-RS | 90610000 | Brazil |
| Altana Pharma/Nycomed | Rio de Janeiro-RJ | 21941590 | Brazil |
| Altana Pharma/Nycomed | Salvador - Bahia | 41920000 | Brazil |
| Altana Pharma/Nycomed | Santo André-SP | 9060650 | Brazil |
| Altana Pharma/Nycomed | Sao Paulo - SP | 5437000 | Brazil |
| Altana Pharma/Nycomed | Sao Paulo-SP | 4025002 | Brazil |
| Altana Pharma/Nycomed | São Paulo-SP | 1221020 | Brazil |
| Altana Pharma/Nycomed | São Paulo-SP | 5403900 | Brazil |
| Altana Pharma/Nycomed | Frankfurt | 60590 | Germany |
| Altana Pharma/Nycomed | Gaißach Bei Bad Tölz | 83674 | Germany |
| Altana Pharma/Nycomed | Geesthacht | 21502 | Germany |
| Altana Pharma/Nycomed | Mainz | 55101 | Germany |
| Altana Pharma/Nycomed | München | 80337 | Germany |
| Altana Pharma/Nycomed | München | 80939 | Germany |
| Altana Pharma/Nycomed | Wesel | 46483 | Germany |
| Altana Pharma/Nycomed | Wiefelstede | 26215 | Germany |
| Altana Pharma/Nycomed | Budapest | 1083 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1089 | Hungary |
| Altana Pharma/Nycomed | Budapest | 1121 | Hungary |
| Altana Pharma/Nycomed | Debrecen | 4012 | Hungary |
| Altana Pharma/Nycomed | Jászberény | 5100 | Hungary |
| Altana Pharma/Nycomed | Miskolc | 3501 | Hungary |
| Altana Pharma/Nycomed | Mosdós | 7257 | Hungary |
| Altana Pharma/Nycomed | Pécs | 7624 | Hungary |
| Altana Pharma/Nycomed | Törökbálint | 2045 | Hungary |
| Altana Pharma/Nycomed | Inowrocław | 88-100 | Poland |
| Altana Pharma/Nycomed | Lodz | 90-141 | Poland |
| Altana Pharma/Nycomed | Lublin | 20-093 | Poland |
| Altana Pharma/Nycomed | Poznan | 60-214 | Poland |
| Altana Pharma/Nycomed | Rzeszów | 35-301 | Poland |
| Altana Pharma/Nycomed | Warsaw | 01-211 | Poland |
| Altana Pharma/Nycomed | Warsaw | 03-924 | Poland |
| Altana Pharma/Nycomed | Zawadzkie | 46-059 | Poland |
| Altana Pharma/Nycomed | Amadora | 2720276 | Portugal |
| Altana Pharma/Nycomed | Faro | 8000-386 | Portugal |
| Altana Pharma/Nycomed | Guimarães | 4800055 | Portugal |
| Altana Pharma/Nycomed | Lisbon | 1269-098 | Portugal |
| Altana Pharma/Nycomed | Lisbon | 1649035 | Portugal |
| Altana Pharma/Nycomed | Lisbon | 1990050 | Portugal |
| Altana Pharma/Nycomed | Matosinhos Municipality | 4450024 | Portugal |
| Altana Pharma/Nycomed | Oliveira de Azeméis | 3720000 | Portugal |
| Altana Pharma/Nycomed | Porto | 4099-001 | Portugal |
| Altana Pharma/Nycomed | Porto | 4200319 | Portugal |
| Altana Pharma/Nycomed | Setúbal | 2910446 | Portugal |
| Altana Pharma/Nycomed | Viana do Castelo | 4901858 | Portugal |
| Altana Pharma/Nycomed | Vila Nova de Gaia | 4400-123 | Portugal |
| Altana Pharma/Nycomed | Bellville - Cape Town - | 7530 | South Africa |
| Altana Pharma/Nycomed | Cape Town | 7937 | South Africa |
| Altana Pharma/Nycomed | Morningside, Sandton | 2196 | South Africa |
| Altana Pharma/Nycomed | Mowbray, Cape Town | 7925 | South Africa |
| Altana Pharma/Nycomed | Panorama / RSA-Cape Town | 7500 | South Africa |
| Altana Pharma/Nycomed | Westville | 3630 | South Africa |
| Altana Pharma/Nycomed | Wynberg | 7945 | South Africa |
| 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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