Study of MAP0010 in Asthmatic Children and Adolescents

A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks

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.

Inclusion Criteria:

• Male or female asthmatic children/adolescents
• 1 to 18 years of age
• FEV1 greater than or equal to 50% predicted normal (where obtainable)
• Stable but symptomatic
• Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.

Exclusion Criteria:

• Any other significant childhood illness.
• Participated in any investigational clinical trial within the 30 days prior to screening.
• Use of any corticosteroid within 2 weeks of screening.
• Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
• Use of inhaled long acting bronchodilators.
• Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
• Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
• History suggestive (or diagnosis) of other concomitant lung disease.