NCT00381485

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED)

A 12-Week Efficacy and Safety Study of Two Doses of Mometasone Furoate/Formoterol Combination Formulation Compared With Mometasone Furoate Monotherapy, in Persistent Asthmatics Previously Treated With High-Dose Inhaled Glucocorticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 834 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mometasone furoate/formoterol (MF/F) combination	MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
DRUG	Mometasone furoate/formoterol (MF/F) combination	MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
DRUG	Mometasone furoate MDI (MF MDI)	MF 400 mcg via metered dose inhaler twice daily for 12 weeks

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2006-09-27
• Last updated: 2024-05-20
• Results posted: 2011-03-07