Titratable dosing in moderate to severe asthmatics
Study identifier:SD-039-0728
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 52 wk Randomized, doubleblind, single dummy, parallel group multicenter Phase 3 study comparing the long term safety of Symbicort pMDI 4x160/4.5mcg bid to SymbicortpMDI 2x160/4.5mcg bid & budesonide HFA pMDI 4x160mcg bid in adult and adolescent subjects with asthma
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
budesonide/formoterol, Symbicort pMDI + budesonide HFA pMDI
Sex
All
Actual Enrollment
570
Study type
Interventional
Age
12 Years +
Date
Study Start Date: 01 Aug 2003
Primary Completion Date: -
Study Completion Date: 01 Jan 2005
Study design
Allocation: Randomized
Endpoint Classification: Safety 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 |
|---|---|
| Experimental: 1 | - |
| Sham Comparator: 2 | Drug: Symbicort pMDI + budesonide HFA pMDI Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg |
Contacts
Investigators
Principal Investigator
Catherine Bonuccelli
AstraZeneca
