Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans

Completed · Phase 4

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00702325

Run by

AstraZeneca

People needed

311

Starts

2008-06-01

Expected to finish

2009-09-01

Last updated by the study team

2012-11-09

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Inverness, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Ocala, Florida, United States
• Research Site — Tallahassee, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Alpharetta, Georgia, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Lawrenceville, Georgia, United States
• Research Site — Lithia Springs, Georgia, United States
• Research Site — Lovejoy, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Hagerstown, Maryland, United States
• Research Site — Lanham, Maryland, United States
• Research Site — Largo, Maryland, United States
• Research Site — Towson, Maryland, United States
• Research Site — Flint, Michigan, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Las Vegas, Nevada, United States
• Research Site — Skillman, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — North Syracuse, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Waterbury, Connecticut, United States

Full record on ClinicalTrials.gov

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