NCT00995904

Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma

A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	84ug MAP0020	84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
DRUG	42ug MAP0020	42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
DRUG	21ug MAP0020	21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-10-15
• Last updated: 2014-01-09
• Results posted: 2013-11-20

Locations

2 sites across 1 country: United States