Status:
COMPLETED
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
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) subjec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT00702325
Start Date
June 1 2008
End Date
September 1 2009
Last Update
November 9 2012
Active Locations (57)
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1
Research Site
Pell City, Alabama, United States
2
Research Site
Bentonville, Arkansas, United States
3
Research Site
Hot Springs, Arkansas, United States
4
Research Site
Little Rock, Arkansas, United States