Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 208
Healthy volunteers: no

Brief summary:
The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

Detailed description:

Arms:
arm 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks arm 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks arm 3: Placebo delivered by nebulization twice daily for 6 weeks

Interventions: intervention 1: MAP0010 low dose intervention 2: MAP0010 high dose intervention 3: Placebo
Intervention descriptions: intervention 1: a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks intervention 2: a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks intervention 3: Placebo delivered by nebulization twice daily for 6 weeks

Protocol document: