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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Collaborator: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
• Treatments: Budesonide

Criteria

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.