At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma (Phase 2; Protocol No. P04223AM3)
In Brief
A Phase 2 clinical trial evaluating Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg, Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg, and 4 other interventions for Asthma. Completed, enrolled 583 participants.
Detailed Summary
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second \[FEV1\]) across 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler (MDI) twice a day (BID) compared with Placebo in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.
Study Details
Timeline
Interventions
MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks
MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks
MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks
MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks
Placebo MDI, 2 puffs BID for 12 weeks
Placebo DPI, 1 puff QD for 12 weeks