NCT00569192

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 12 Months – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	0.135mg MAP0010	0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
DRUG	0.25mg MAP0010	0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
DRUG	Placebo	Placebo delivered by nebulization twice daily for 12 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-09-01
• Completion: 2009-01-01
• First posted: 2007-12-07
• Last updated: 2014-01-09
• Results posted: 2013-10-23