New Breath Actuated MDI Symbicort compared to Symbicort pMDI and Budesonide pMDI for 12 weeks twice a day - BAI
Study identifier:D589OC00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A 12-week, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy safety, and patient use (User Study) of Symbicort® (budesonide/formoterol) Breath Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg twice daily compared with Symbicort (budesonide/formoterol) AC (actuation counter) pMDI® 2x160/4.5 μg twice daily and budesonide AC pMDI 2x160 μg twice daily in adult and adolescent asthmatics
Medical condition
asthma
Phase
Phase 3
Healthy volunteers
No
Study drug
Symbicort, Budesonide
Sex
All
Actual Enrollment
214
Study type
Interventional
Age
12 Years +
Date
Study Start Date: 01 Nov 2011
Primary Completion Date: 01 Aug 2012
Study Completion Date: 01 Aug 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 Symbicort/inhaler Symbicort BA MDI 2x160/4.5 μg twice daily | Drug: Symbicort Breath actuated metered dose inhaler |
| Active Comparator: Symbicort/inhaler Symbicort AC pDMI 2x160/4.5 μg twice daily | Drug: Symbicort Actuation counter pressured metered dose inhaler |
| Active Comparator: Budesonide/inhaler Budesonide AC pMDI 2x160 μg twice daily | Drug: Budesonide Actuation counter pressured metered dose inhaler |
Contacts
Investigators
Principal Investigator
Goran Eckerwall
AstraZeneca R&D, Mölndal
