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

Tracking Information

First Received Date ^ICMJE

January 9, 2007

Last Updated Date

March 26, 2009

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Post-study medication FEV1 [ Time Frame: 1 hour after medication ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Post-study medication FEV1(1 hour after medication)

Change History

Complete list of historical versions of study NCT00421122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

FVC [ Time Frame: Pre dose and 1 hour post dose ] [ Designated as safety issue: No ]
FEV1 [ Time Frame: Pre-dose and 15 minutes post dose ] [ Designated as safety issue: No ]
SGRQ symptom scores
COPD symptom scores
morning and evening PEF [ Time Frame: Assessed daily ] [ Designated as safety issue: No ]
reliever medication use
AE
lab measures
ECG
physician examination
vital signs

Original Secondary Outcome Measures ^ICMJE

pre-study medication and 1hour post study medication FVC
pre study medication and 15 min. post study medication FEV1
SGRQ symptom scores
COPD symptom scores
morning and evening PEF
reliever medication use
AE
lab measures
ECG
physician examination
vital signs

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: Bricasol®
Experimental: Bricasol® + Pulmicort®
Experimental: Bricasol® + Symbicort®

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

315

Completion Date

November 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00421122

Responsible Party

Study ID Numbers ^ICMJE

D5892C00013

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Symbicort Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP