Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421122
• Other study ID #: D5892C00013
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2007
• Last updated: March 26, 2009
• Start date: September 2006
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Chengdu	Sichuan
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Nanjing	Jiangsu
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoling
China	Research Site	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-study medication FEV1		1 hour after medication	No
Secondary	FVC		Pre dose and 1 hour post dose	No
Secondary	FEV1		Pre-dose and 15 minutes post dose	No
Secondary	SGRQ symptom scores
Secondary	COPD symptom scores
Secondary	morning and evening PEF		Assessed daily	No
Secondary	reliever medication use
Secondary	AE
Secondary	lab measures
Secondary	ECG
Secondary	physician examination
Secondary	vital signs