Overview

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

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Formoterol Fumarate
Terbutaline
Criteria
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