Comparison between Symbicort® and prednisolone in COPD - SPACE
Study identifier:D5892L00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A randomised, double blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort® forte Turbuhaler®) and oral prednisolone + formoterol (Oxis® Turbuhaler) during two weeks, in COPD patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort forte Turbuhaler)
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
budesonide/formoterol, Prednisolone
Sex
All
Actual Enrollment
120
Study type
Interventional
Age
40 Years +
Date
Study Start Date: 01 Sept 2005
Primary Completion Date: -
Study Completion Date: 01 Jul 2007
Study design
Allocation: Randomized
Endpoint Classification: 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
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Contacts
Investigators
Principal Investigator
AstraZeneca Symbicort Medical Science Director
AstraZeneca
