Efficacy and safety study of Symbicort Turbuhaler in Chinese patients with COPD
Study identifier:D5892C00013
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
budesonide/formoterol (Symbicort), budesonide (Pulmicort), terbutaline sulfate (Bricasol)
Sex
All
Actual Enrollment
315
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Sept 2006
Primary Completion Date: -
Study Completion Date: 01 Nov 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Bricasol® | Drug: terbutaline sulfate (Bricasol) inhalation therapy Other Name: Bricasol pMDI |
| Experimental: 2 Bricasol® + Pulmicort® | Drug: budesonide (Pulmicort) inhalation Other Name: Pulmicort® Turbuhaler Drug: terbutaline sulfate (Bricasol) inhalation therapy Other Name: Bricasol pMDI |
| Experimental: 3 Bricasol® + Symbicort® | Drug: budesonide/formoterol (Symbicort) inhalation therapy Other Name: Symbicort® Turbuhaler Drug: terbutaline sulfate (Bricasol) inhalation therapy Other Name: Bricasol pMDI |
Contacts
Investigators
Principal Investigator
Symbicort Medical Science Director
AstraZeneca
