Efficacy of Symbicort versus its monocomponents - SPRUCE 80/4.5
Study identifier:SD-039-0716
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 12 week Randomized, Double-blind, Double-Dummy, Placebo-controlled Trial of Symbicort TM (160/4.5mcg) versus its Mono-Products (budesonide and formoterol) in children (at least 6years of age) and adults with Asthma-SPRUCE 80/4.5
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
budesonide/formoterol, budesonide, formoterol
Sex
All
Actual Enrollment
450
Study type
Interventional
Age
6 Years +
Date
Study Start Date: 01 Aug 2002
Primary Completion Date: -
Study Completion Date: 01 Sept 2003
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 |
|---|---|
| Experimental: 1 Symbicort | - |
| Active Comparator: 2 budesonide | - |
| Active Comparator: 3 formoterol | - |
Contacts
Investigators
Principal Investigator
Catherine Bonuccelli
AstraZeneca
