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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | July 16, 2008 | ||||||||
| Start Date ICMJE | January 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
FEV1 absolute values. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00163397 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137) | ||||||||
| Official Title ICMJE | A Comparative Study of Inhaled Ciclesonide 160 Mcg/Day vs Budesonide 400 Mcg/Day in Patients With Asthma | ||||||||
| Brief Summary | The aim of the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 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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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Asthma | ||||||||
| Intervention ICMJE | Drug: Ciclesonide | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 120 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Malaysia, Taiwan | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00163397 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | BY9010/M1-137 | ||||||||
| Study Sponsor ICMJE | ALTANA Pharma | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | ALTANA Pharma | ||||||||
| Verification Date | July 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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