Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102)
This study has been completed.
Sponsor:
Takeda
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00404547
First received: November 27, 2006
Last updated: May 4, 2012
Last verified: March 2010
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| Tracking Information | |||||
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| First Received Date ICMJE | November 27, 2006 | ||||
| Last Updated Date | May 4, 2012 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | April 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in Mean of Total Score of Asthma Control Questionnaire (ACQ) [ Time Frame: At the middle and end of the 12 week treatment period ] [ Designated as safety issue: No ] The score of the change from baseline ranges from -6 (=best possible outcome) to 6 (=worst possible outcome). |
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| Original Primary Outcome Measures ICMJE |
Change in mean score of total score of Asthma Control Questionnaire (ACQ) | ||||
| Change History | Complete list of historical versions of study NCT00404547 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Change in mean score of patient assessment of asthma control, Comparison between change in patient assessment of asthma control and change in ACQ, Assessment of patient compliance during the study, Assessment of patient treatment satisfaction | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Asthma Care With Alvesco® (Ciclesonide) in Primary Care in Adults - The ACCEPT-study (BY9010/CA-102) | ||||
| Official Title ICMJE | An Open-Label Randomized, Multicenter Study in Patients With Asthma to Evaluate the Effectiveness of Alvesco® (Ciclesonide) Compared to Asthma Usual Care in a Primary Practice Setting | ||||
| Brief Summary | The purpose of this study is to investigate the effectiveness of Alvesco® (Ciclesonide) compared with usual asthma care in the primary care setting. Patients with a history of asthma for at least 6 months and who, in the opinion of the physician, meet the clinical requirements for treatment with inhaled steroids (ICS) will be enrolled. They will either receive Alvesco® or usual care. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1121 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | April 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 and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00404547 | ||||
| Other Study ID Numbers ICMJE | BY9010/CA-102 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Nycomed GmbH (Ex ALTANA Pharma) | ||||
| Study Sponsor ICMJE | Takeda | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Takeda | ||||
| Verification Date | March 2010 | ||||
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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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