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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

315 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Bricasol®

Group Type ACTIVE_COMPARATOR

terbutaline sulfate (Bricasol)

Intervention Type DRUG

inhalation therapy

2

Bricasol® + Pulmicort®

Group Type EXPERIMENTAL

budesonide (Pulmicort)

Intervention Type DRUG

inhalation

terbutaline sulfate (Bricasol)

Intervention Type DRUG

inhalation therapy

3

Bricasol® + Symbicort®

Group Type EXPERIMENTAL

budesonide/formoterol (Symbicort)

Intervention Type DRUG

inhalation therapy

terbutaline sulfate (Bricasol)

Intervention Type DRUG

inhalation therapy

Interventions

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budesonide/formoterol (Symbicort)

inhalation therapy

Intervention Type DRUG

budesonide (Pulmicort)

inhalation

Intervention Type DRUG

terbutaline sulfate (Bricasol)

inhalation therapy

Intervention Type DRUG

Other Intervention Names

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Symbicort® Turbuhaler Pulmicort® Turbuhaler Bricasol pMDI

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No