A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age

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.

Inclusion Criteria:

• Male or female asthmatic children with mild to moderate persistent asthma.
• 12 months to 8 years of age.
• For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
• For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
• AND with at least one major or two minor risk factors.

Exclusion Criteria:

• Any other significant childhood illness/abnormality or chronic lung disease
• Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
• Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
• Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
• Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.