Official Title: “A Two Stage Randomized, Open-Label, Parallel Group, Phase III, Multicenter, 7 Month Study to Assess the Efficacy & Safety of SYMBICORT pMDI Adminstered Either as Fixed or as an Adjustable Regimen Versus a Fixed Regimen of Advair in Subjects 12 Yrs of Age and Older With Asthma.”

The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

• Drug: budesonide/formoterol (Symbicort)
• Drug: fluticasone/salmeterol (Advair)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • budesonide/formoterol
• Active Comparator: 2
  • fluticasone/salmeterol

Primary Measures

• Asthma control assessed by asthma exacerbations
  • Time Frame: Continuosly throughout the treatment period
    

Secondary Measures

• Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.
  • Time Frame: Daily and at 1, 3 and 6 months after start of treatmen
    
• Use of medical resources and medication for the treatment of asthma.
  • Time Frame: Throughout the treatment period
    
• Investigate safety profile of Symbicort compared to Advair
  • Time Frame: 1, 3 and 6 months after start of treatment and 1 week after end of tretment
    

Inclusion Criteria:

• Diagnosis of asthma
• Baseline lung function tests as determined by protocol
• Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol

Exclusion Criteria:

• Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a beta-blockers
• Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

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

Mitchell Golmand, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00646594

Study ID Number: D5896C00005

ClinicalTrials.gov Identifier: NCT00646594

Health Authority: United States: Food and Drug Administration