Study to Investigate the Efficacy of Symbicort SMART (SAKURA)
Tracking Information
Start Date ICMJE | February 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: February 9, 2009) | Asthma exacerbations [ Time Frame: daily ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00839800 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: February 9, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Study to Investigate the Efficacy of Symbicort SMART. |
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Official Title ICMJE | A Comparison of Symbicort® SMART (160/4.5μg) and Symbicort Turbuhaler 160/4.5 μg, Plus Terbutaline Turbuhaler 0.4 mg as Needed, for Treatment of Asthma - a 12-month, Randomized, Double-blind, Parallel Group, Active-controlled, Multinational Phase III Study in Asthmatic Patients From 16 Years |
Brief Summary | The primary objective of this study is to compare the efficacy of Symbicort SMART (Symbicort Turbuhaler 160/4.5μg, one inhalation bid plus as needed) with Symbicort Turbuhaler 160/4.5μg, one inhalation bid plus terbutaline Turbuhaler 0.4 mg as needed, as asthma therapy |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Condition ICMJE | Asthma |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 1800 | ||||
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Estimated Completion Date | February 2011 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 16 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Argentina, Brazil, China, Costa Rica, Hungary, India, Japan, Korea, Republic of, Malaysia, Peru, Philippines, Russian Federation, Thailand |
Administrative Information
NCT ID ICMJE | NCT00839800 | ||||||||
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Responsible Party | Tomas Andersson, MD, Medical Science Director Symbicort, AstraZeneca | ||||||||
Study ID Numbers ICMJE | D589LC00001 | ||||||||
Study Sponsor ICMJE | AstraZeneca | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | AstraZeneca |
Source: http://clinicaltrials.gov/