NCT00697801

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	MAP0010 low dose	a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
DRUG	MAP0010 high dose	a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
DRUG	Placebo	Placebo delivered by nebulization twice daily for 6 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2008-06-16
• Last updated: 2014-01-09
• Results posted: 2013-10-23

Locations

1 site across 1 country: United States