NCT00554970

A Study of 2 Doses of MAP0010 in Adult Asthmatics

A Randomized, Open Label, Active-Controlled, 4-Treatment, 2-Period, 2 Parallel Block Crossover Pharmacokinetic and Safety Study of 2 Doses of MAP0010 in Adult Asthmatics

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	MAP0010 low dose	a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
DRUG	MAP0010 high dose	a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
DRUG	Budesonide inhalation suspension 0.25mg	a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
DRUG	Budesonide inhalation suspension 0.5mg	a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-01-01
• Completion: 2008-03-01
• First posted: 2007-11-07
• Last updated: 2014-01-09
• Results posted: 2013-10-23

Locations

1 site across 1 country: United States