Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | September 12, 2005 | ||||||||
Last Updated Date | July 16, 2008 | ||||||||
Start Date † | January 2004 | ||||||||
Current Primary Outcome Measures † |
FEV1 absolute values. | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00163397 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
|
||||||||
Original Secondary Outcome Measures † |
|
||||||||
Descriptive Information | |||||||||
Brief Title † | Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137) | ||||||||
Official Title † | 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. |
||||||||
Detailed Description | |||||||||
Study Phase | Phase III | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Asthma | ||||||||
Intervention † | Drug: Ciclesonide | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Completed | ||||||||
Enrollment † | 120 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Main Inclusion Criteria:
Main Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | Malaysia, Taiwan | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00163397 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | ALTANA Pharma | ||||||||
Collaborators †† | |||||||||
Investigators † |
|
||||||||
Information Provided By | ALTANA Pharma | ||||||||
Verification Date | July 2008 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |