Study identifier:D589OC00003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
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
asthma
Phase 3
No
Symbicort, Budesonide
All
214
Interventional
12 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Oct 2013 by AstraZeneca
AstraZeneca
-
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.
Location
Location
Huntington Beach, California, United States
Location
Long Beach, California, United States
Location
Los Angeles, California, United States
Location
Orange, California, United States
Location
Rancho Mirage, California, United States
Location
Riverside, California, United States
Location
Sacramento, California, United States
Location
San Diego, California, United States
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 |
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