Official Title: “A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD”

This study aims at evaluating efficacy and safety of Symbicort® Turbuhaler® in Chinese COPD patients as defined by GOLD treatment guidelines in order to obtain an approval for indication of COPD from Chinese State Food and Drug Administration.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: budesonide/formoterol (Symbicort)
  • inhalation therapy
• Drug: budesonide (Pulmicort)
  • inhalation
• Drug: terbutaline sulfate (Bricasol)
  • inhalation therapy

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Bricasol®
• Experimental: 2
  • Bricasol® + Pulmicort®
• Experimental: 3
  • Bricasol® + Symbicort®

Primary Measures

• Post-study medication FEV1
  • Time Frame: 1 hour after medication
    Safety Issue?: No

Secondary Measures

• FVC
  • Time Frame: Pre dose and 1 hour post dose
    Safety Issue?: No
• FEV1
  • Time Frame: Pre-dose and 15 minutes post dose
    Safety Issue?: No
• SGRQ symptom scores
• COPD symptom scores
• morning and evening PEF
  • Time Frame: Assessed daily
    Safety Issue?: No
• reliever medication use
• AE
• lab measures
• ECG
• physician examination
• vital signs

Inclusion Criteria:

• Signed and dated inform consent
• Out-patient, clinical diagnosis of COPD
• Men or women at the age of 40 or over

Exclusion Criteria:

• A history of asthma
• Seasonal allergic rhinitis before 40 years of age
• Patients with significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, uncontrolled hypertension as defined by the investigator or other disorder

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 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

Symbicort Medical Science Director, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00421122

Study ID Number: D5892C00013

ClinicalTrials.gov Identifier: NCT00421122

Health Authority: China: State Food and Drug Administration