At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Mometasone furoate/formoterol (MF/F) combination and Mometasone furoate MDI (MF MDI) for Asthma. Completed, enrolled 834 participants.
Detailed 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).
Study Details
Timeline
Interventions
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 12 weeks
MF 400 mcg via metered dose inhaler twice daily for 12 weeks