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A 6-Month, Phase IIIA, Multi-Center,Randomised,Double-Blind, Double-Dummy, Parallel-Group Study of the Efficacy and Safety of Symbicort® Turbuhaler®+ Bricasol® pMDI Compared With Pulmicort® Turbuhaler®+Bricasol® pMDI in Chinese Patients With COPD
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.
Details
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 315 |
| Start date | 2006-09 |
| Completion | 2007-11 |
Conditions
- Chronic Obstructive Pulmonary Disease
Interventions
- budesonide/formoterol (Symbicort)
- budesonide (Pulmicort)
- terbutaline sulfate (Bricasol)
Primary outcomes
- Post-study medication FEV1 — 1 hour after medication
Countries
China