At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 1-Year Safety Study of Medium and High Doses of Mometasone Furoate/Formoterol Combination Formulation and Medium and High Doses of Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Medium to High Doses of Inhaled Glucocorticosteroids
In Brief
A Phase 3 clinical trial evaluating mometasone furoate combination MDI 200/10 mcg BID, mometasone furoate combination MDI 400/10 mcg BID, and 2 other interventions for Asthma. Completed, enrolled 404 participants.
Detailed Summary
The purpose of this study is to evaluate the long-term safety of mometasone furoate/formoterol (MF/F) metered dose inhaler (MDI) 200/10 mcg twice-a-day (BID) and MF/F MDI 400/10 mcg BID and two doses of fluticasone/salmeterol combination (F/SC) (250/50 mcg BID and 500/50 mcg BID) in subjects with persistent asthma who require maintenance treatment on inhaled glucocorticosteroids (ICS); evaluator-blind. In addition, the extrapulmonary effects on 24-hour plasma cortisol area under curve (AUC), of MF/F MDI 200/10 mcg BID, MF/F MDI 400/10 mcg BID, F/SC MDI 250/50 mcg BID, and F/SC MDI 500/50 mcg BID will be evaluated.
Study Details
Timeline
Interventions
MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
F/SC 250/50 twice daily for 1 year
F/SC 500/50 twice daily for 1 year