Conditions: Asthma
Keywords: asthma, children, budesonide pMDI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 882
Healthy volunteers: no

Brief summary:
The purpose is to investigate the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared with Budesonide pMDI 80 μg, 2 Actuations Twice Daily, in Children Ages 6 to \<12 Years with Asthma during 12 weeks.

Detailed description:
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

Arms:
arm 1: Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily arm 2: Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily arm 3: Budesonide pMDI 80µg, 2 acuations twice daily

Interventions: intervention 1: Symbicort pMDI intervention 2: Symbicort pMDI intervention 3: Budesonide pMDI
Intervention descriptions: intervention 1: Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily intervention 2: Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily intervention 3: Budesonide pMDI 80µg, 2 acuations twice daily

Protocol document: