Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
NCT ID: NCT00536913
Last Updated: 2012-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2007-09-30
2008-02-29
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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With Spacer
Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25ug + spacer
Without Spacer
Budesonide/formoterol pMDI 40/2.25 ug
Budesonide/formoterol pMDI 40/2.25 ug
Interventions
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Budesonide/formoterol pMDI 40/2.25ug + spacer
Budesonide/formoterol pMDI 40/2.25 ug
Eligibility Criteria
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Inclusion Criteria
* 6 months, PEF
* 50% of predicted normal value pre-bronchodilator
Exclusion Criteria
* current respiratory infection
* any significant disease or disorder as judged by investigator
6 Years
11 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Tomas Anderson, MD PhD
Role: STUDY_DIRECTOR
AstraZeneca
Piotr Kuna, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Uniwersytecki Spital
Locations
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Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Kaposvár, , Hungary
Research Site
Bialystok, , Poland
Research Site
Bydgoszcz, , Poland
Research Site
Bytom, , Poland
Research Site
Karpacz, , Poland
Research Site
Krakow, , Poland
Research Site
Lodz, , Poland
Research Site
Warsaw, , Poland
Research Site
Moscow, , Russia
Countries
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Other Identifiers
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D5897C00004
Identifier Type: -
Identifier Source: org_study_id
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