Conditions: Asthma
Keywords: asthma, children, budesonide pMDI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 304
Healthy volunteers: no

Brief summary:
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

Detailed description:
Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to \<12 years with asthma

Arms:
arm 1: Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid) arm 2: Placebo pMDI 2 inhalations bid

Interventions: intervention 1: budesonide intervention 2: placebo
Intervention descriptions: intervention 1: pMDI, inhalation, bid, 6 weeks intervention 2: pMDI, inhalation, bid, 6 weeks

Protocol document: