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Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

NCT ID: NCT00702325

Last Updated: 2012-11-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-09-30

Brief Summary

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To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Detailed Description

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Conditions

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Asthma

Keywords

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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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1

Group Type EXPERIMENTAL

Budesonide / formoterol fumarate (SYMBICORT)

Intervention Type DRUG

160/4.5 μg x 2 actuations twice daily (bid)

2

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

inhalation powder 180 μg x 2 inhalations bid (PULMICORT)

Interventions

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Budesonide / formoterol fumarate (SYMBICORT)

160/4.5 μg x 2 actuations twice daily (bid)

Intervention Type DRUG

Budesonide

inhalation powder 180 μg x 2 inhalations bid (PULMICORT)

Intervention Type DRUG

Other Intervention Names

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SYMBICORT PULMICORT

Eligibility Criteria

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Inclusion Criteria

* African American (self-reported)
* Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
* FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.

Exclusion Criteria

* Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
* Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
* Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
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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Ubaldo Martin, MD

Role: STUDY_DIRECTOR

AstraZeneca

Tomas LG Andersson

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Pell City, Alabama, United States

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Bentonville, Arkansas, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Malvern, Arkansas, United States

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Huntington Park, 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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Los Angles, California, United States

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Orange, California, United States

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Rolling Hills Estates, California, United States

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Centennial, Colorado, United States

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Colorado Springs, Colorado, United States

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Waterbury, Connecticut, United States

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Inverness, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Decatur, Georgia, United States

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Lawrenceville, Georgia, United States

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Lithia Springs, Georgia, United States

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Lovejoy, Georgia, United States

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Chicago, Illinois, United States

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Hagerstown, Maryland, United States

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Lanham, Maryland, United States

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Largo, Maryland, United States

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Towson, Maryland, United States

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Flint, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Skillman, New Jersey, United States

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New York, New York, United States

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North Syracuse, New York, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Portland, Oregon, United States

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Blue Bell, Pennsylvania, United States

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Charleston, South Carolina, United States

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Spartanburg, South Carolina, United States

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Memphis, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Waco, Texas, United States

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Emporia, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

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.

Reference Type DERIVED
PMID: 22329608 (View on PubMed)

Other Identifiers

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D589BL00003

Identifier Type: -

Identifier Source: org_study_id