Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chinese patients, 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.
Interventions
inhalation therapy
inhalation
DRUGterbutaline sulfate (Bricasol)
inhalation therapy
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-study medication FEV1 | 1 hour after medication |
Secondary
| Measure | Time frame |
|---|---|
| FEV1 | Pre-dose and 15 minutes post dose |
| SGRQ symptom scores | — |
| COPD symptom scores | — |
| morning and evening PEF | Assessed daily |
| reliever medication use | — |
| FVC | Pre dose and 1 hour post dose |
| lab measures | — |
| ECG | — |
| physician examination | — |
| vital signs | — |
| AE | — |
Countries
China
Outcome results
None listed