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The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Ciclesonide 40 µg |
|
| 2 | Active Comparator | Ciclesonide 80 µg |
|
| 3 | Active Comparator | Ciclesonide 160 µg |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciclesonide | Drug | Efficacy and Safety of Ciclesonide |
| |
| Measure | Description | Time Frame |
|---|---|---|
| time to first moderate or severe asthma exacerbation. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| rate of patients with moderate or severe asthma exacerbation | 24 weeks | |
| rate of patients with moderate asthma exacerbation | 24 weeks | |
| rate of patients with severe asthma exacerbation |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21839625 | Derived | Brand PL, Luz Garcia-Garcia M, Morison A, Vermeulen JH, Weber HC. Ciclesonide in wheezy preschool children with a positive asthma predictive index or atopy. Respir Med. 2011 Nov;105(11):1588-95. doi: 10.1016/j.rmed.2011.07.017. Epub 2011 Aug 11. |
| Label | URL |
|---|---|
| BY9010-M1-207-DEU RDS-2008-03-20.pdf | View source |
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| Placebo |
| Drug |
Placebo |
|
| 24 weeks |
| time to first moderate asthma exacerbation | 24 weeks |
| time to first severe asthma exacerbation | 24 weeks |
| asthma symptom score from diary | 24 weeks |
| use of rescue medication | 24 weeks |
| patient perceived asthma control | 24 weeks |
| quality of life data (PACQLQ) | 24 weeks |
| morning and evening PEF from diary | 24 weeks |
| pulmonary function variables measured at the investigational sites | 24 weeks |
| adverse events | 24 weeks |
| physical examination | 24 weeks |
| vital signs | 24 weeks |
| laboratory work-up | 24 weeks |
| serum cortisol | 24 weeks |
| urine cortisol variables | 24 weeks |
| body growth determined by stadiometry. | 24 weeks |
| Curitiba-PR |
| 80060900 |
| Brazil |
| Altana Pharma/Nycomed | Paraná | 80060900 | Brazil |
| Altana Pharma/Nycomed | Pinheiros Sao Paulo - SP | 1246-000 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre-RS | 90035003 | Brazil |
| Altana Pharma/Nycomed | Porto Alegre-RS | 90610000 | Brazil |
| Altana Pharma/Nycomed | Recife-PE | 50670901 | Brazil |
| Altana Pharma/Nycomed | Rio de Janeiro-RJ | 21941590 | Brazil |
| Altana Pharma/Nycomed | Rio Grande | 90610000 | 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 | 1277900 | Brazil |
| Altana Pharma/Nycomed | São Paulo | 5403900 | Brazil |
| Altana Pharma/Nycomed | São Paulo | 5651 | Brazil |
| Altana Pharma/Nycomed | São Paulo | Brazil |
| Altana Pharma/Nycomed | São Paulo-SP | 1221020 | Brazil |
| Altana Pharma/Nycomed | Berlin | 13353 | Germany |
| Altana Pharma/Nycomed | Cologne | 50924 | Germany |
| Altana Pharma/Nycomed | Dresden | 1307 | Germany |
| Altana Pharma/Nycomed | Düsseldorf | 40225 | Germany |
| Altana Pharma/Nycomed | Frankfurt | 60590 | Germany |
| Altana Pharma/Nycomed | Heidelberg | 69120 | Germany |
| Altana Pharma/Nycomed | Mannheim | 68167 | Germany |
| Altana Pharma/Nycomed | München | 80939 | Germany |
| Altana Pharma/Nycomed | Rosenheim | 83026 | Germany |
| Altana Pharma/Nycomed | Wesel | 46483 | Germany |
| Altana Pharma/Nycomed | Wiefelstede | 26215 | Germany |
| Altana Pharma/Nycomed | Baja | 6500 | Hungary |
| 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 | Kaposvár | 7400 | Hungary |
| Altana Pharma/Nycomed | Kiskunhalas | 6400 | Hungary |
| Altana Pharma/Nycomed | Miskolc | 3501 | Hungary |
| Altana Pharma/Nycomed | Mosdós | 7257 | Hungary |
| Altana Pharma/Nycomed | Mosonmagyaróvár | 9200 | Hungary |
| Altana Pharma/Nycomed | NyÃregyháza | 4400 | Hungary |
| Altana Pharma/Nycomed | Pécs | 7624 | Hungary |
| Altana Pharma/Nycomed | Szeged | 6720 | Hungary |
| Altana Pharma/Nycomed | Szekszárd | 7100 | Hungary |
| Altana Pharma/Nycomed | Törökbálint | 2045 | Hungary |
| Altana Pharma/Nycomed | Chandanwadi, Thane | 400061 | India |
| Altana Pharma/Nycomed | Chennai | 600 034 | India |
| Altana Pharma/Nycomed | Coimbatore | 641 014 | India |
| Altana Pharma/Nycomed | Coimbatore | 641004 | India |
| Altana Pharma/Nycomed | Coimbatore, Tamilnadu | 641 044 | India |
| Altana Pharma/Nycomed | Kalaburagi | 585104 | India |
| Altana Pharma/Nycomed | Mumbai | 400 004 | India |
| Altana Pharma/Nycomed | Mumbai | 400008 | India |
| Altana Pharma/Nycomed | Mumbai, Dadar (E) | 400 014 | India |
| Altana Pharma/Nycomed | Nagpur | 12 | India |
| Altana Pharma/Nycomed | Noida | 201301 | India |
| Altana Pharma/Nycomed | Pune | 411 001 | India |
| Altana Pharma/Nycomed | Pune | 411 033 | India |
| Altana Pharma/Nycomed | Eindhoven | 5623 EJ | Netherlands |
| Altana Pharma/Nycomed | Enschede | 7511 JX | Netherlands |
| Altana Pharma/Nycomed | Hoofddorp | 2134 TM | Netherlands |
| Altana Pharma/Nycomed | Leeuwarden | 8901 BR | Netherlands |
| Altana Pharma/Nycomed | Nijmegen | 6532 SZ | Netherlands |
| Altana Pharma/Nycomed | Zwolle | 8025 AB | Netherlands |
| Altana Pharma/Nycomed | Karpacz | 58-540 | Poland |
| Altana Pharma/Nycomed | Lublin | 20-093 | Poland |
| Altana Pharma/Nycomed | Opole | 45401 | Poland |
| Altana Pharma/Nycomed | Poznan | 60-214 | Poland |
| Altana Pharma/Nycomed | Poznan | 60-693 | Poland |
| Altana Pharma/Nycomed | Zawadzkie | 46-059 | Poland |
| Altana Pharma/Nycomed | Bellville - Cape Town - | 7530 | South Africa |
| Altana Pharma/Nycomed | Cape Town | 7937 | South Africa |
| Altana Pharma/Nycomed | Durban | 3630 | South Africa |
| Altana Pharma/Nycomed | Morningside, Sandton | 2196 | South Africa |
| Altana Pharma/Nycomed | Mowbray, Cape Town | 7925 | South Africa |
| Altana Pharma/Nycomed | New Redruth, Alberton | 1450 | South Africa |
| Altana Pharma/Nycomed | Overport, Durban | 4091 | South Africa |
| Altana Pharma/Nycomed | Panorama / RSA-Cape Town | 7500 | South Africa |
| Altana Pharma/Nycomed | Pietermaritzburg | 3201 | South Africa |
| Altana Pharma/Nycomed | Westville | 3630 | South Africa |
| Altana Pharma/Nycomed | Wynberg | 7945 | South Africa |
| Altana Pharma/Nycomed | Barcelona | 8003 | Spain |
| Altana Pharma/Nycomed | Barcelona | 8023 | Spain |
| Altana Pharma/Nycomed | Barcelona | 8222 | Spain |
| Altana Pharma/Nycomed | El Palmar (Murcia) | 30120 | Spain |
| Altana Pharma/Nycomed | Elche - Alicante | 3203 | Spain |
| Altana Pharma/Nycomed | Leganes (Madrid) | 28911 | Spain |
| Altana Pharma/Nycomed | Madrid | 28006 | Spain |
| Altana Pharma/Nycomed | Madrid | 28009 | Spain |
| Altana Pharma/Nycomed | Madrid | 28041 | Spain |
| Altana Pharma/Nycomed | Sabadell | 8208 | Spain |
| Altana Pharma/Nycomed | Seville | 41071 | Spain |
| Altana Pharma/Nycomed | Valencia | 46009 | Spain |
| Altana Pharma/Nycomed | Lausanne | 1011 | Switzerland |
| Altana Pharma/Nycomed | Trimbach | 4632 | Switzerland |
| Altana Pharma/Nycomed | Zurich | 8032 | Switzerland |
| 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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