Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: budesonide (Pulmicort)Drug: budesonide/formoterol (Symbicort)Drug: terbutaline sulfate (Bricasol)
- Registration Number
- NCT00421122
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 315
Inclusion Criteria
- Signed and dated inform consent
- Out-patient, clinical diagnosis of COPD
- Men or women at the age of 40 or over
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 terbutaline sulfate (Bricasol) Bricasol® + Pulmicort® 1 terbutaline sulfate (Bricasol) Bricasol® 2 budesonide (Pulmicort) Bricasol® + Pulmicort® 3 budesonide/formoterol (Symbicort) Bricasol® + Symbicort® 3 terbutaline sulfate (Bricasol) Bricasol® + Symbicort®
- Primary Outcome Measures
Name Time Method Post-study medication FEV1 1 hour after medication
- Secondary Outcome Measures
Name Time Method FVC Pre dose and 1 hour post dose reliever medication use AE lab measures ECG physician examination vital signs FEV1 Pre-dose and 15 minutes post dose SGRQ symptom scores morning and evening PEF Assessed daily COPD symptom scores
Trial Locations
- Locations (1)
Research Site
🇨🇳Hangzhou, Zhejiang, China