A comparison of Symbicort® pMDI 2 x 160/4.5 μg bid and Symbicort® pMDI 2 x 80/4.5 μg bid with formoterol Turbuhaler®, budesonide pMDI, the combination of formoterol Turbuhaler® and budesonide pMDI, and placebo in COPD Patients
Study identifier:D5899C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 6-Month Double-blind, Double-dummy, Randomized, Parallel group, Multicenter Efficacy & Safety Study of SYMBICORT® pMDI 2 x 160/4.5 µg & 80/4.5 µg bid Compared to Formoterol TBH, Budesonide pMDI (& the combination) & Placebo in COPD Patients
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
Budesonide/formoterol pMDI, Budesonide pMDI, Formoterol Turbuhaler
Sex
All
Actual Enrollment
1500
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Apr 2005
Primary Completion Date: -
Study Completion Date: 01 Dec 2006
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
Loading...
No locations available
| Arms | Assigned Interventions |
|---|
Contacts
Investigators
Principal Investigator
AstraZeneca Symbicort Medical Science Director
AstraZeneca
