Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
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
1 other identifier
interventional
315
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease
Started Sep 2006
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 9, 2007
CompletedFirst Posted
Study publicly available on registry
January 11, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMarch 27, 2009
March 1, 2009
January 9, 2007
March 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-study medication FEV1
1 hour after medication
Secondary Outcomes (11)
FVC
Pre dose and 1 hour post dose
FEV1
Pre-dose and 15 minutes post dose
SGRQ symptom scores
COPD symptom scores
morning and evening PEF
Assessed daily
- +6 more secondary outcomes
Study Arms (3)
1
ACTIVE COMPARATORBricasol®
2
EXPERIMENTALBricasol® + Pulmicort®
3
EXPERIMENTALBricasol® + Symbicort®
Interventions
Eligibility Criteria
You may qualify if:
- Signed and dated inform consent
- Out-patient, clinical diagnosis of COPD
- Men or women at the age of 40 or over
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (8)
Research Site
Beijing, Beijing Municipality, China
Research Site
Guangzhou, Guangdong, China
Research Site
Nanjing, Jiangsu, China
Research Site
Shenyang, Liaoling, China
Research Site
Shanghai, Shanghai Municipality, China
Research Site
Xi’an, Shanxi, China
Research Site
Chengdu, Sichuan, China
Research Site
Hangzhou, Zhejiang, China
Related Publications (1)
Zhong N, Zheng J, Wen F, Yang L, Chen P, Xiu Q, Yao W, Sun T, Zhao Z, Shen H, Shi Y, Lin J, Li Q. Efficacy and safety of budesonide/formoterol via a dry powder inhaler in Chinese patients with chronic obstructive pulmonary disease. Curr Med Res Opin. 2012 Feb;28(2):257-65. doi: 10.1185/03007995.2011.636420. Epub 2012 Jan 20.
PMID: 22046961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Symbicort Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 9, 2007
First Posted
January 11, 2007
Study Start
September 1, 2006
Study Completion
November 1, 2007
Last Updated
March 27, 2009
Record last verified: 2009-03