At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Mometasone Furoate/Formoterol Fumarate Combination MDI 100/10 mcg BID, Mometasone Furoate MDI (MF MDI), and 2 other interventions for Asthma. Completed, enrolled 746 participants.
Detailed 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.
Study Details
Timeline
Interventions
MF/F 100/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks
MF 100 mcg via metered dose inhaler twice daily for 26 weeks
F via metered dose inhaler 10 mcg twice a day for 26 weeks
Placebo metered dose inhaler twice a day for 26 weeks