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

NCT ID: NCT00419952

Last Updated: 2012-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Moderate Asthma Severe Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Symbicort

Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)

Group Type EXPERIMENTAL

Budesonide/formoterol (SYMBICORT) pMDI

Intervention Type DRUG

Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)

Budesonide

Budesonide HFA pMDI 160 ug x 2 actuations BID

Group Type EXPERIMENTAL

Budesonide HFA pMDI

Intervention Type DRUG

Budesonide HFA pMDI 160 ug x 2 actuations BID

Interventions

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Budesonide/formoterol (SYMBICORT) pMDI

Symbicort pMDI 160/4.5 ug x 2 actuations twice daily (BID)

Intervention Type DRUG

Budesonide HFA pMDI

Budesonide HFA pMDI 160 ug x 2 actuations BID

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christer Hultquist, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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

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Countries

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United States

Related Links

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http://www.asthmaclinicaltrials.com

Related Info

Other Identifiers

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D5896C00022

Identifier Type: -

Identifier Source: org_study_id