NCT00379288

Study of Mometasone Furoate/Formoterol Combination and Fluticasone/Salmeterol in Persistent Asthmatics Previously Treated With Inhaled Glucocorticosteroids (P04139)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 404 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	mometasone furoate combination MDI 200/10 mcg BID	MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
DRUG	mometasone furoate combination MDI 400/10 mcg BID	MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
DRUG	Fluticasone/Salmeterol 250/50 mcg BID	F/SC 250/50 twice daily for 1 year
DRUG	Fluticasone/Salmeterol 500/50 mcg BID	F/SC 500/50 twice daily for 1 year

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-09-21
• Last updated: 2024-05-20
• Results posted: 2010-08-12