Overview

Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)

Status:
Completed

Trial end date:
2008-09-01

Target enrollment:

Participant gender:

Summary

This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 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) [Time Frame: Baseline to Week 12] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

Phase:

Phase 3

Details

Lead Sponsor:

Merck Sharp & Dohme Corp.

Collaborator:

Novartis

Treatments:

Formoterol Fumarate
Mometasone Furoate