A Safety and Efficacy Study of Symbicort Turbuhaler Compared With Standard Chronic Obstructive Pulmonary Disease (COPD) Treatment in Japan
NCT ID: NCT01070784
Last Updated: 2014-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
328 participants
INTERVENTIONAL
2010-01-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Symbicort Turbuhaler (Budesonide/formoterol)
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
2
Drug: any available COPD treatment; investigator to decide
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
Interventions
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Symbicort Turbuhaler (Budesonide/formoterol)
2 x 160/4.5 microgram, inhalation, bid, 52 weeks
Drug: any available COPD treatment; investigator to decide
According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented COPD symptoms for more than 2 years
* Pre-bronchodilator FEV1≦50% of predicted normal value, and post-bronchodilator FEV1/FVC\<70%
Exclusion Criteria
* Subjects with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder as judged by the investigator
* COPD exacerbation during the run-in period or within 4 weeks prior to registration, requiring hospitalization and/or treatment with systemic steroids.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas Andersson, MD
Role: STUDY_CHAIR
AstraZeneca, R&D, Lund, Sweden
Locations
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Research Site
Nagoya, Aichi-ken, Japan
Research Site
Toyota, Aichi-ken, Japan
Research Site
Yanagawa, Fukuoka, Japan
Research Site
Hiroshima, Hiroshima, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Itami, Hyōgo, Japan
Research Site
Hitachi, Ibaraki, Japan
Research Site
Tsukuba, Ibaraki, Japan
Research Site
Sakaidechō, Kagawa-ken, Japan
Research Site
Fujisawa, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kōshi, Kumamoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Murata, Miyagi, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Setagaya City, Tokyo, Japan
Countries
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Related Links
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Other Identifiers
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D589DC00008
Identifier Type: -
Identifier Source: org_study_id
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