Back to resultsEfficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
budesonide/formoterol (Symbicort)
budesonide (Pulmicort)
terbutaline sulfate (Bricasol)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chinese patients, COPD
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Bricasol®
Bricasol® + Pulmicort®
Bricasol® + Symbicort®
Outcomes
Primary Outcome Measures
Post-study medication FEV1
Secondary Outcome Measures
FVC
FEV1
SGRQ symptom scores
COPD symptom scores
morning and evening PEF
reliever medication use
AE
lab measures
ECG
physician examination
vital signs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00421122
Brief Title
Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
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 Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chinese patients, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
315 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bricasol®
Arm Title
2
Arm Type
Experimental
Arm Description
Bricasol® + Pulmicort®
Arm Title
3
Arm Type
Experimental
Arm Description
Bricasol® + Symbicort®
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol (Symbicort)
Other Intervention Name(s)
Symbicort® Turbuhaler
Intervention Description
inhalation therapy
Intervention Type
Drug
Intervention Name(s)
budesonide (Pulmicort)
Other Intervention Name(s)
Pulmicort® Turbuhaler
Intervention Description
inhalation
Intervention Type
Drug
Intervention Name(s)
terbutaline sulfate (Bricasol)
Other Intervention Name(s)
Bricasol pMDI
Intervention Description
inhalation therapy
Primary Outcome Measure Information:
Title
Post-study medication FEV1
Time Frame
1 hour after medication
Secondary Outcome Measure Information:
Title
FVC
Time Frame
Pre dose and 1 hour post dose
Title
FEV1
Time Frame
Pre-dose and 15 minutes post dose
Title
SGRQ symptom scores
Title
COPD symptom scores
Title
morning and evening PEF
Time Frame
Assessed daily
Title
reliever medication use
Title
AE
Title
lab measures
Title
ECG
Title
physician examination
Title
vital signs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Symbicort Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Research Site
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Research Site
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Research Site
City
Shenyang
State/Province
Liaoling
Country
China
Facility Name
Research Site
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Research Site
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
Research Site
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Research Site
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
22046961
Citation
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.
Results Reference
derived
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Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
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