Atlantis Symbicort
Study identifier:D5896C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A two stage randomized, open-label, parallel group, phase III, multicenter, 7 month study to assess the efficacy & safety of SYMBICORT pMDI adminstered either as fixed or as an adjustable regimen versus a fixed regimen of Advair in subjects 12 yrs of age and older with asthma.
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
budesonide/formoterol (Symbicort), fluticasone/salmeterol (Advair)
Sex
All
Actual Enrollment
1200
Study type
Interventional
Age
12 Years +
Date
Study Start Date: 01 Nov 2003
Primary Completion Date: -
Study Completion Date: 01 Jan 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 budesonide/formoterol | - |
| Active Comparator: 2 fluticasone/salmeterol | - |
Contacts
Investigators
Principal Investigator
Mitchell Golmand
AstraZeneca
