Official Title: “A 12-wk, Rand., Double-Blind, Double Dummy, Multi-Ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2009

Intervention(s) in this Clinical Trial

• Drug: Budesonide /formoterol fumarate
  • 160/4.5 μg x 2 actuations twice daily (bid)
• Drug: Budesonide
  • inhalation powder 180 μg x 2 inhalations bid

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• change from baseline in the pre-dose forced expiratory volume in one second (FEV1) averaged over the double-blind treatment period
  • Time Frame: at clinical visit
    Safety Issue?: No

Secondary Measures

• AM Peak Expiratory Flow (PEF)
  • Time Frame: Daily, across treatment period
    Safety Issue?: No
• PM Peak Expiratory Flow (PEF)
  • Time Frame: Daily, across treatment period
    Safety Issue?: No
• Spirometry Measures [forced vital capacity (FVC), forced expiratory flow (FEF)]
  • Time Frame: at clinical visit
    Safety Issue?: No

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

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

Ubaldo Martin, MD Study Director AstraZeneca  

Overall Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702325

Study ID Number: D589BL00003

ClinicalTrials.gov Identifier: NCT00702325

Health Authority: United States: Food and Drug Administration