A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
A 52-week, Randomised, Double-blind, Parallel-group, Multi-centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORT® pMDI 160/4.5 mg x 2 Actuations Twice Daily to Budesonide HFA pMDI 160 mg x 2 Actuations Twice Daily in Adult/Adolescent (≥12 Years) African American Subjects With Asthma
1 other identifier
interventional
742
1 country
122
Brief Summary
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Feb 2007
Typical duration for phase_3 asthma
122 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2007
CompletedFirst Posted
Study publicly available on registry
January 9, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
October 30, 2012
CompletedOctober 30, 2012
September 1, 2012
2.8 years
January 5, 2007
November 30, 2010
September 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Number of Asthma Exacerbations
An exacerbation was defined as symptomatic worsening requiring oral/systemic glucocorticoid therapy and/or emergency room visit and/or urgent care center visit and/or hospitalization.
52 Weeks
Secondary Outcomes (13)
Asthma Exacerbations
52 Weeks
QT Interval Corrected Using the Fridericia Formula Measured Via Electrocardiogram (ECG)
Baseline and 52 weeks
Number of Patients With Shift From Normal to High Rate of Total Ectopic Ventricular Beats as Measured by 24-hour Holter Monitor Assessment
Baseline and 2 weeks (visit 4)
Number of Patients With Shift From Normal to High Rate of Total Ectopic Supraventricular Beats as Measured by 24-hour Holter Monitor Assessment
Baseline and 2 weeks (visit 4)
Total Number of Ventricular Runs as Measured by 24-hour Holter Monitor Assessment
Baseline and 2 weeks (visit 4)
- +8 more secondary outcomes
Study Arms (2)
Symbicort
EXPERIMENTALSymbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Budesonide
EXPERIMENTALBudesonide HFA pMDI 160 ug x 2 actuations BID
Interventions
Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)
Eligibility Criteria
You may qualify if:
- Male or Female, African American (self-reported), ≥12 years of age
- Moderate to severe asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
You may not qualify if:
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- Any significant disease or disorder that may jeopardize a subject's safety
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (122)
Research Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Muscle Shoals, Alabama, United States
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Phoenix, Arizona, United States
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Little Rock, Arkansas, United States
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Buena Park, California, United States
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Foothill Ranch, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Riverside, California, United States
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Rolling Hills Estates, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Torrance, California, United States
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Winnetka, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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Altamonte Springs, Florida, United States
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Clearwater, Florida, United States
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Destin, Florida, United States
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Gainesville, Florida, United States
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Hollywood, Florida, United States
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Miami, Florida, United States
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Opa-locka, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Port Charlotte, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Columbus, Georgia, United States
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Gainesville, Georgia, United States
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Savannah, Georgia, United States
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Stone Mountain, Georgia, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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River Forest, Illinois, United States
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Indianapolis, Indiana, United States
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Merrillville, Indiana, United States
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South Bend, Indiana, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Owensboro, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Bogalusa, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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Monroe, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Sunset, Louisiana, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Mitchellville, Maryland, United States
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Montgomery Village, Maryland, United States
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Wheaton, Maryland, United States
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Russells Mills, Massachusetts, United States
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Bay City, Michigan, United States
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Paw Paw, Michigan, United States
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Saginaw, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Prentiss, Mississippi, United States
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Vicksburg, Mississippi, United States
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Omaha, Nebraska, United States
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Blackwood, New Jersey, United States
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Cherry Hill, New Jersey, United States
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Teaneck, New Jersey, United States
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Verona, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Newburgh, New York, United States
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North Syracuse, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Tonawanda, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Highpoint, North Carolina, United States
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Mooresville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Lyndhurst, Ohio, United States
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Parma, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Beaver, Pennsylvania, United States
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Collegeville, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Havertown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Simpsonville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, United States
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Chattanooga, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Killeen, Texas, United States
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Missouri City, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Sugarland, Texas, United States
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Waco, Texas, United States
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Hampton, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Springfield, Virginia, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Christer Hultquist, MD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2007
First Posted
January 9, 2007
Study Start
February 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
October 30, 2012
Results First Posted
October 30, 2012
Record last verified: 2012-09