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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Budesonide/formoterol (SYMBICORT) pMDI
• Drug: Budesonide HFA pMDI

Primary Measures

• 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 Measures

• 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Christer Hultquist, MD Study Director AstraZeneca  

Overall Contact: AstraZeneca Clinical Study Information 800-280-7155 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00419952

Study ID Number: D5896C00022

ClinicalTrials.gov Identifier: NCT00419952

Health Authority: United States: Food and Drug Administration