Conditions: Asthma
Keywords: asthmatic children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 360
Healthy volunteers: no

Brief summary:
The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

Detailed description:

Arms:
arm 1: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks arm 2: Placebo delivered by nebulization twice daily for 12 weeks arm 3: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Interventions: intervention 1: 0.135mg MAP0010 intervention 2: 0.25mg MAP0010 intervention 3: Placebo
Intervention descriptions: intervention 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks intervention 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks intervention 3: Placebo delivered by nebulization twice daily for 12 weeks

Protocol document: