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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00421122

D5892C00013

Details and patient eligibility

About

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.

Enrollment: 315 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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315 participants in 3 patient groups

1

Active Comparator group

Description:

Bricasol®

Treatment:

Drug: terbutaline sulfate (Bricasol)

2

Experimental group

Description:

Bricasol® + Pulmicort®

Treatment:

Drug: budesonide (Pulmicort)

Drug: terbutaline sulfate (Bricasol)

3

Experimental group

Description:

Bricasol® + Symbicort®

Treatment:

Drug: budesonide/formoterol (Symbicort)

Drug: terbutaline sulfate (Bricasol)