A Comparison of SYMBICORT pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol (SYMBICORT) pMDI (Drug); Budesonide HFA pMDI (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christer Hultquist, MD, Study Director, Affiliation: AstraZeneca

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-280-7155, Email: information.center@astrazeneca.com

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.

Official title: A 52-Week, Randomised, Double-Blind, Parallel-Group, Multi-Centre, Phase IIIB Study Comparing the Long Term Safety of SYMBICORTÒ 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To assess the long-term safety profile of SYMBICORT pMDI 160/4.5 μg x 2 actuations twice daily compared to budesonide HFA pMDI 160 μg x 2 actuations twice daily, in African American subjects with moderate to severe asthma, over a 52-week treatment perio

Secondary outcome:

Patient reported outcome variables over a 52-week treatment period collected using Onset of Effect Questionnaire to assess pre-dose FEV1 and morning peak expiratory flow (AM PEF)

To collect a blood sample for pharmacogenetic analyses in all subjects

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- Subjects requiring treatment with systemic corticosteroids (e. g., oral, parenteral,

ocular)

- Any significant disease or disorder that may jeopardize a subject's safety

AstraZeneca Clinical Study Information, Phone: 800-280-7155, Email: information.center@astrazeneca.com

Research Site, Mobile, Alabama, United States; Recruiting

Research Site, Montgomery, Alabama, United States; Recruiting

Research Site, Phoenix, Arizona, United States; Recruiting

Research Site, Little Rock, Arkansas, United States; Recruiting

Research Site, Foothill Ranch, California, United States; Recruiting

Research Site, Long Beach, California, United States; Recruiting

Research Site, Los Angeles, California, United States; Recruiting

Research Site, Riverside, California, United States; Recruiting

Research Site, Rolling Hills Estates, California, United States; Recruiting

Research Site, San Diego, California, United States; Recruiting

Research Site, Stockton, California, United States; Recruiting

Research Site, Torrance, California, United States; Recruiting

Research Site, Colorado Springs, Colorado, United States; Recruiting

Research Site, Denver, Colorado, United States; Recruiting

Research Site, Newark, Delaware, United States; Recruiting

Research Site, Washington, District of Columbia, United States; Recruiting

Research Site, Altamonte Springs, Florida, United States; Recruiting

Research Site, Clearwater, Florida, United States; Not yet recruiting

Research Site, Gainesville, Florida, United States; Recruiting

Research Site, Miami, Florida, United States; Recruiting

Research Site, Opa Locka, Florida, United States; Recruiting

Research Site, Orlando, Florida, United States; Recruiting

Research Site, Pensacola, Florida, United States; Recruiting

Research Site, Port Charlotte, Florida, United States; Recruiting

Research Site, South Miami, Florida, United States; Recruiting

Research Site, Tampa, Florida, United States; Recruiting

Research Site, West Palm Beach, Florida, United States; Recruiting

Research Site, Albany, Georgia, United States; Recruiting

Research Site, Augusta, Georgia, United States; Recruiting

Research Site, Columbus, Georgia, United States; Recruiting

Research Site, Gainesville, Georgia, United States; Recruiting

Research Site, Savannah, Georgia, United States; Recruiting

Research Site, Stone Mountain, Georgia, United States; Recruiting

Research Site, Atlanta, Georgia, United States; Recruiting

Research Site, Chicago, Illinois, United States; Recruiting

Research Site, Peoria, Illinois, United States; Recruiting

Research Site, River Forest, Illinois, United States; Recruiting

Research Site, South Bend, Indiana, United States; Recruiting

Research Site, Valparaiso, Indiana, United States; Recruiting

Research Site, Topeka, Kansas, United States; Recruiting

Research Site, Wichita, Kansas, United States; Recruiting

Research Site, Owensboro, Kentucky, United States; Recruiting

Research Site, Baton Rouge, Louisiana, United States; Recruiting

Research Site, Mandeville, Louisiana, United States; Recruiting

Research Site, Metairie, Louisiana, United States; Recruiting

Research Site, Monroe, Louisiana, United States; Recruiting

Research Site, New Orleans, Louisiana, United States; Recruiting

Research Site, Shreveport, Louisiana, United States; Recruiting

Research Site, Marrero, Louisiana, United States; Recruiting

Research Site, Sunset, Louisiana, United States; Recruiting

Research Site, Baltimore, Maryland, United States; Recruiting

Research Site, Bethesda, Maryland, United States; Recruiting

Research Site, Mitchellville, Maryland, United States; Recruiting

Research Site, Potomac, Maryland, United States; Not yet recruiting

Research Site, Wheaton, Maryland, United States; Recruiting

Research Site, Dartmouth, Massachusetts, United States; Recruiting

Research Site, Bay City, Michigan, United States; Recruiting

Research Site, Paw Paw, Michigan, United States; Recruiting

Research Site, Southfield, Michigan, United States; Recruiting

Research Site, Vicksburg, Mississippi, United States; Not yet recruiting

Research Site, St. Louis, Missouri, United States; Not yet recruiting

Research Site, Omaha, Nebraska, United States; Recruiting

Research Site, Blackwood, New Jersey, United States; Recruiting

Research Site, Cherry Hill, New Jersey, United States; Recruiting

Research Site, Teaneck, New Jersey, United States; Recruiting

Research Site, Verona, New Jersey, United States; Recruiting

Research Site, Bronx, New York, United States; Recruiting

Research Site, Brooklyn, New York, United States; Recruiting

Research Site, Great Neck, New York, United States; Recruiting

Research Site, New York, New York, United States; Not yet recruiting

Research Site, Newburgh, New York, United States; Recruiting

Research Site, North Syracuse, New York, United States; Recruiting

Research Site, Rochester, New York, United States; Recruiting

Research Site, Asheville, North Carolina, United States; Recruiting

Research Site, Charlotte, North Carolina, United States; Recruiting

Research Site, Greensboro, North Carolina, United States; Recruiting

Research Site, Hickory, North Carolina, United States; Recruiting

Research Site, Highpoint, North Carolina, United States; Recruiting

Research Site, Winston-Salem, North Carolina, United States; Recruiting

Research Site, Cincinnati, Ohio, United States; Recruiting

Research Site, Cleveland, Ohio, United States; Not yet recruiting

Research Site, Toledo, Ohio, United States; Recruiting

Research Site, Oklahoma City, Oklahoma, United States; Recruiting

Research Site, Beaver, Pennsylvania, United States; Recruiting

Research Site, Collegeville, Pennsylvania, United States; Recruiting

Research Site, Harrisburg, Pennsylvania, United States; Recruiting

Research Site, Havertown, Pennsylvania, United States; Recruiting

Research Site, Upland, Pennsylvania, United States; Recruiting

Research Site, Yardley, Pennsylvania, United States; Recruiting

Research Site, Pittsburg, Pennsylvania, United States; Recruiting

Research Site, Columbia, South Carolina, United States; Recruiting

Research Site, Greenville, South Carolina, United States; Recruiting

Research Site, Simpsonville, South Carolina, United States; Recruiting

Research Site, Spartanburg, South Carolina, United States; Recruiting

Research Site, Union, South Carolina, United States; Recruiting

Research Site, Chattanooga, Tennessee, United States; Recruiting

Research Site, Killeen, Texas, United States; Recruiting

Research Site, Missouri City, Texas, United States; Recruiting

Research Site, San Antonio, Texas, United States; Recruiting

Research Site, Sugarland, Texas, United States; Recruiting

Research Site, Waco, Texas, United States; Recruiting

Research Site, Hampton, Virginia, United States; Recruiting

Research Site, Norfolk, Virginia, United States; Recruiting

Research Site, Richmond, Virginia, United States; Recruiting

Starting date: February 2007
Ending date: June 2010
Last updated: September 29, 2008