An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
NCT ID: NCT00419757
Last Updated: 2012-08-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
558 participants
INTERVENTIONAL
2007-01-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Symbicort
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide/formoterol (SYMBICORT) pMDI
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide
budesonide HFA pMDI 160 μg x 2 actuations twice daily
Budesonide HFA pMDI
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Interventions
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Budesonide/formoterol (SYMBICORT) pMDI
SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
Budesonide HFA pMDI
Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe asthma requiring treatment with an inhaled corticosteroid
* Diagnosis of asthma for at least 6 months
Exclusion Criteria
* Any significant disease or disorder that may jeopardize a subject's safety
12 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Christer Hultquist, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Anaheim, California, United States
Research Site
Chula Vista, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Los Angeles, California, United States
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National City, California, United States
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Rancho Cordova, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Pueblo, Colorado, United States
Research Site
Largo, Florida, United States
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Miami, Florida, United States
Research Site
Naranja, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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South Miami, Florida, United States
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Chicago, Illinois, United States
Research Site
Newburgh, New York, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Boerne, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Spring, Texas, United States
Research Site
Aguas Buenas, , Puerto Rico
Research Site
Caquas, , Puerto Rico
Research Site
Cidra, , Puerto Rico
Research Site
Levittown, , Puerto Rico
Research Site
Ponce, , Puerto Rico
Research Site
SanJuan, , Puerto Rico
Research Site
Trujillo Alto, , Puerto Rico
Countries
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References
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Murphy KR, Uryniak T, Martin UJ, Zangrilli J. The effect of budesonide/formoterol pressurized metered-dose inhaler on predefined criteria for worsening asthma in four different patient populations with asthma. Drugs R D. 2012 Mar 1;12(1):9-14. doi: 10.2165/11630600-000000000-00000.
Zangrilli J, Mansfield LE, Uryniak T, O'Brien CD. Efficacy of budesonide/formoterol pressurized metered-dose inhaler versus budesonide pressurized metered-dose inhaler alone in Hispanic adults and adolescents with asthma: a randomized, controlled trial. Ann Allergy Asthma Immunol. 2011 Sep;107(3):258-65.e2. doi: 10.1016/j.anai.2011.05.024. Epub 2011 Jul 14.
Related Links
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Related Info
Other Identifiers
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D5896C00021
Identifier Type: -
Identifier Source: org_study_id