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

March 26, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, China
        • Research Site
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Research Site
    • Liaoling
      • Shenyang, Liaoling, China
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, China
        • Research Site
    • Shanxi
      • Xi'an, Shanxi, China
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, China
        • Research Site
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Bricasol®
Drug: terbutaline sulfate (Bricasol)
inhalation therapy
Other Names:
  • Bricasol pMDI
EXPERIMENTAL: 2
Bricasol® + Pulmicort®
Drug: terbutaline sulfate (Bricasol)
inhalation therapy
Other Names:
  • Bricasol pMDI
Drug: budesonide (Pulmicort)
inhalation
Other Names:
  • Pulmicort® Turbuhaler
EXPERIMENTAL: 3
Bricasol® + Symbicort®
Drug: terbutaline sulfate (Bricasol)
inhalation therapy
Other Names:
  • Bricasol pMDI
Drug: budesonide/formoterol (Symbicort)
inhalation therapy
Other Names:
  • Symbicort® Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-study medication FEV1
Time Frame: 1 hour after medication
1 hour after medication

Secondary Outcome Measures

Outcome Measure
Time Frame
vital signs
ECG
FVC
Time Frame: Pre dose and 1 hour post dose
Pre dose and 1 hour post dose
FEV1
Time Frame: Pre-dose and 15 minutes post dose
Pre-dose and 15 minutes post dose
SGRQ symptom scores
COPD symptom scores
morning and evening PEF
Time Frame: Assessed daily
Assessed daily
reliever medication use
AE
lab measures
physician examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Symbicort Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (ACTUAL)

November 1, 2007

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (ESTIMATE)

January 11, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 27, 2009

Last Update Submitted That Met QC Criteria

March 26, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5892C00013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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