Official Title: “A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.”

The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study

Study Primary Completion Date: September 2003

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • budesonide/formoterol
• Active Comparator: 2
  • fluticasone/salmeterol
• Active Comparator: 3
  • albuterol

Primary Measures

• FEV1 3 minutes post dose
  • Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
    

Secondary Measures

• 12 hour serial FEV1
  • Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
    
• Patients perception of effect
  • Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)
    

Inclusion Criteria:

• Diagnosis of asthma and baseline lung function test results as determined by protocol
• Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion Criteria:

• Severe asthma or asthma markedly affected by seasonal factors
• Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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

Catherine Bonuccelli Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00646620

Study ID Number: SD-039-0732

ClinicalTrials.gov Identifier: NCT00646620

Health Authority: United States: Food and Drug Administration