Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
NCT ID: NCT00163449
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2005-11-30
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TRIPLE
Study Groups
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1
Ciclesonide 40 µg
Ciclesonide
Efficacy and Safety of Ciclesonide
2
Ciclesonide 80 µg
Ciclesonide
Efficacy and Safety of Ciclesonide
3
Ciclesonide 160 µg
Ciclesonide
Efficacy and Safety of Ciclesonide
4
Placebo
Placebo
Placebo
Interventions
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Ciclesonide
Efficacy and Safety of Ciclesonide
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Outpatients
* Good health with the exception of asthma
* Documented diagnosis of asthma for more than 6 months
* Use of rescue medication only or pretreatment with a controller drug
Exclusion Criteria
* Diseases contraindicated for the use of inhaled steroids
* Other relevant lung diseases causing impairment in pulmonary function
* Recurrent, episodic wheezing only
* History of life-threatening asthma
* History of any mechanical ventilation
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Premature birth (\< 32 weeks gestation)
2 Years
6 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Altana Pharma/Nycomed
Campinas - SP, , Brazil
Altana Pharma/Nycomed
Curitiba-PR, , Brazil
Altana Pharma/Nycomed
Paraná, , Brazil
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, , Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, , Brazil
Altana Pharma/Nycomed
Porto Alegre-RS, , Brazil
Altana Pharma/Nycomed
Recife-PE, , Brazil
Altana Pharma/Nycomed
Rio de Janeiro-RJ, , Brazil
Altana Pharma/Nycomed
Rio Grande, , Brazil
Altana Pharma/Nycomed
Salvador - Bahia, , Brazil
Altana Pharma/Nycomed
Santo André-SP, , Brazil
Altana Pharma/Nycomed
Sao Paulo - SP, , Brazil
Altana Pharma/Nycomed
Sao Paulo-SP, , Brazil
Altana Pharma/Nycomed
São Paulo, , Brazil
Altana Pharma/Nycomed
São Paulo, , Brazil
Altana Pharma/Nycomed
São Paulo, , Brazil
Altana Pharma/Nycomed
São Paulo, , Brazil
Altana Pharma/Nycomed
São Paulo-SP, , Brazil
Altana Pharma/Nycomed
Berlin, , Germany
Altana Pharma/Nycomed
Cologne, , Germany
Altana Pharma/Nycomed
Dresden, , Germany
Altana Pharma/Nycomed
Düsseldorf, , Germany
Altana Pharma/Nycomed
Frankfurt, , Germany
Altana Pharma/Nycomed
Heidelberg, , Germany
Altana Pharma/Nycomed
Mannheim, , Germany
Altana Pharma/Nycomed
München, , Germany
Altana Pharma/Nycomed
Rosenheim, , Germany
Altana Pharma/Nycomed
Wesel, , Germany
Altana Pharma/Nycomed
Wiefelstede, , Germany
Altana Pharma/Nycomed
Baja, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Budapest, , Hungary
Altana Pharma/Nycomed
Debrecen, , Hungary
Altana Pharma/Nycomed
Jászberény, , Hungary
Altana Pharma/Nycomed
Kaposvár, , Hungary
Altana Pharma/Nycomed
Kiskunhalas, , Hungary
Altana Pharma/Nycomed
Miskolc, , Hungary
Altana Pharma/Nycomed
Mosdós, , Hungary
Altana Pharma/Nycomed
Mosonmagyaróvár, , Hungary
Altana Pharma/Nycomed
Nyíregyháza, , Hungary
Altana Pharma/Nycomed
Pécs, , Hungary
Altana Pharma/Nycomed
Szeged, , Hungary
Altana Pharma/Nycomed
Szekszárd, , Hungary
Altana Pharma/Nycomed
Törökbálint, , Hungary
Altana Pharma/Nycomed
Chandanwadi, Thane, , India
Altana Pharma/Nycomed
Chennai, , India
Altana Pharma/Nycomed
Coimbatore, , India
Altana Pharma/Nycomed
Coimbatore, , India
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, , India
Altana Pharma/Nycomed
Kalaburagi, , India
Altana Pharma/Nycomed
Mumbai, , India
Altana Pharma/Nycomed
Mumbai, , India
Altana Pharma/Nycomed
Mumbai, Dadar (E), , India
Altana Pharma/Nycomed
Nagpur, , India
Altana Pharma/Nycomed
Noida, , India
Altana Pharma/Nycomed
Pune, , India
Altana Pharma/Nycomed
Pune, , India
Altana Pharma/Nycomed
Eindhoven, , Netherlands
Altana Pharma/Nycomed
Enschede, , Netherlands
Altana Pharma/Nycomed
Hoofddorp, , Netherlands
Altana Pharma/Nycomed
Leeuwarden, , Netherlands
Altana Pharma/Nycomed
Nijmegen, , Netherlands
Altana Pharma/Nycomed
Zwolle, , Netherlands
Altana Pharma/Nycomed
Karpacz, , Poland
Altana Pharma/Nycomed
Lublin, , Poland
Altana Pharma/Nycomed
Opole, , Poland
Altana Pharma/Nycomed
Poznan, , Poland
Altana Pharma/Nycomed
Poznan, , Poland
Altana Pharma/Nycomed
Zawadzkie, , Poland
Altana Pharma/Nycomed
Bellville - Cape Town -, , South Africa
Altana Pharma/Nycomed
Cape Town, , South Africa
Altana Pharma/Nycomed
Durban, , South Africa
Altana Pharma/Nycomed
Morningside, Sandton, , South Africa
Altana Pharma/Nycomed
Mowbray, Cape Town, , South Africa
Altana Pharma/Nycomed
New Redruth, Alberton, , South Africa
Altana Pharma/Nycomed
Overport, Durban, , South Africa
Altana Pharma/Nycomed
Panorama / RSA-Cape Town, , South Africa
Altana Pharma/Nycomed
Pietermaritzburg, , South Africa
Altana Pharma/Nycomed
Westville, , South Africa
Altana Pharma/Nycomed
Wynberg, , South Africa
Altana Pharma/Nycomed
Barcelona, , Spain
Altana Pharma/Nycomed
Barcelona, , Spain
Altana Pharma/Nycomed
Barcelona, , Spain
Altana Pharma/Nycomed
El Palmar (Murcia), , Spain
Altana Pharma/Nycomed
Elche - Alicante, , Spain
Altana Pharma/Nycomed
Leganes (Madrid), , Spain
Altana Pharma/Nycomed
Madrid, , Spain
Altana Pharma/Nycomed
Madrid, , Spain
Altana Pharma/Nycomed
Madrid, , Spain
Altana Pharma/Nycomed
Sabadell, , Spain
Altana Pharma/Nycomed
Seville, , Spain
Altana Pharma/Nycomed
Valencia, , Spain
Altana Pharma/Nycomed
Lausanne, , Switzerland
Altana Pharma/Nycomed
Trimbach, , Switzerland
Altana Pharma/Nycomed
Zurich, , Switzerland
Countries
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References
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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.
Related Links
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BY9010-M1-207-DEU RDS-2008-03-20.pdf
Other Identifiers
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BY9010/M1-207
Identifier Type: -
Identifier Source: org_study_id