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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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
Research Site
Fresno, California, United States
Research Site
Fullerton, California, United States
Research Site
Los Angeles, California, United States
Research Site
National City, California, United States
Research Site
Rancho Cordova, California, United States
Research Site
Rancho Mirage, California, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
Research Site
San Diego, California, United States
Research Site
San Francisco, California, United States
Research Site
Stockton, California, United States
Research Site
Torrance, California, United States
Research Site
Pueblo, Colorado, United States
Research Site
Largo, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Naranja, Florida, United States
Research Site
North Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Panama City, Florida, United States
Research Site
South Miami, Florida, United States
Research Site
Chicago, Illinois, United States
Research Site
Newburgh, New York, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Boerne, Texas, United States
Research Site
El Paso, Texas, United States
Research Site
Fort Worth, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
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
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