NCT00442351

Efficacy and Tolerability of Maintenance Treatment With Asmanex Twisthaler Versus Placebo in Mild/Moderate Persistent Asthmatics (Study P04654)(TERMINATED)

A Comparative Study of The Efficacy and Tolerability of Maintenance Treatment of Patients With Mild/Moderate Persistent Asthma With Asmanex Twisthaler 220 mcg QD PM Versus "Asmanex" Placebo QD PM

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, placebo-controlled, double-blind, parallel-group study evaluating Asmanex Twisthaler 220 mcg once daily (QD) in the evening (PM) compared with "Asmanex" Placebo QD PM for 12 weeks. Efficacy will be measured for the changes in forced expiratory volume in 1 second (FEV1) from baseline to the end of treatment period (Week 12 or end of the study).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Asmanex twisthaler	Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
OTHER	Placebo for Asmanex twisthaler	Placebo for Asmanex Twisthaler 220 mcg, once daily in the evening for 12 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2007-03-01
• Last updated: 2022-02-09
• Results posted: 2010-04-16