Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: budesonide/formoterol (Symbicort) (Drug); budesonide (Pulmicort) (Drug); terbutaline sulfate (Bricasol) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Post-study medication FEV1
Secondary outcome: FVCFEV1 SGRQ symptom scores COPD symptom scores morning and evening PEF reliever medication use AE lab measures ECG physician examination vital signs
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Research Site, Beijing, China
Research Site, Shanghai, China
Research Site, Guangzhou, Guangdong, China
Research Site, Nanjing, Jiangsu, China
Research Site, Shenyang, Liaoling, China
Research Site, Xi'an, Shanxi, China
Research Site, Chengdu, Sichuan, China
Research Site, Hangzhou, Zhejiang, China
Additional Information
Starting date: September 2006
Ending date: January 2008
Last updated: February 26, 2008
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