Study identifier:D589GC00003
ClinicalTrials.gov identifier:NCT02091986
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 3, 12-Week, Double-Blind, Randomized, Parallel-Group, Multicenter Study Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg, 2 Actuations Twice Daily, and Symbicort pMDI 80/4.5 μg, 2 Actuations Twice Daily, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to <12 Years with Asthma
asthma
Phase 3
No
Symbicort pMDI
All
882
Interventional
6 Years - 11 Years
Allocation: Randomized 
Endpoint Classification: Safety/Efficacy Study 
Intervention Model: Parallel Assignment 
Masking: Double Blind 
Primary Purpose: Treatment 
Verified 01 Feb 2017 by AstraZeneca
AstraZeneca
-
No locations available
| Arms | Assigned Interventions | 
|---|---|
| Active Comparator: Symbicort pMDI 80/2.25 µg Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily  | Drug: Symbicort pMDI  Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily  | 
| Active Comparator: Symbicort pMDI 80/4.5µg Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily  | Drug: Symbicort pMDI  Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily  | 
| Active Comparator: Budesonide pMDI Budesonide pMDI 80µg, 2 acuations twice daily  | Other: Budesonide pMDI  Budesonide pMDI 80µg, 2 acuations twice daily Other Name: Active comparator  |