NCT00383552

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)

A 26-Week Placebo-Controlled Efficacy and Safety Study of Mometasone Furoate/Formoterol Fumarate Combination Formulation Compared With Mometasone Furoate and Formoterol Monotherapy in Subjects With Persistent Asthma Previously Treated With Low-Dose Inhaled Glucocorticosteroids

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (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 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID	MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
DRUG	Mometasone Furoate MDI (MF MDI)	MF 100 mcg via metered dose inhaler twice daily for 26 weeks
DRUG	Formoterol Fumarate 10 mcg	F via metered dose inhaler 10 mcg twice a day for 26 weeks
DRUG	Placebo	Placebo metered dose inhaler twice a day for 26 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2006-10-03
• Last updated: 2024-05-17
• Results posted: 2011-10-25