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| Tracking Information | |||||
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| First Received Date ICMJE | March 22, 2006 | ||||
| Last Updated Date | December 12, 2008 | ||||
| Start Date ICMJE | May 2006 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PC20 (AMP)(Post-treatment compared to baseline) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
PC20 (AMP)(Post–treatment compared to baseline). | ||||
| Change History | Complete list of historical versions of study NCT00306163 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101) | ||||
| Official Title ICMJE | Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone. | ||||
| Brief Summary | The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 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 (Subject, Caregiver, Investigator), Active Control, Parallel Assignment | ||||
| Condition ICMJE | Asthma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| 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 | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Main Inclusion Criteria:
Main Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00306163 | ||||
| Responsible Party | Nycomed GmbH, Nycomed | ||||
| Study ID Numbers ICMJE | BY9010/NL-101 | ||||
| Study Sponsor ICMJE | ALTANA Pharma | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | ALTANA Pharma | ||||
| Verification Date | December 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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