NCT00383721

Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in Chronic Obstructive Pulmonary Disease (COPD) (Study P04230AM4)(COMPLETED)

A Randomized, 26-Week, Placebo-Controlled Efficacy and Safety Study With a 26-Week Long-Term Safety Extension, of High- and Medium-Dose Inhaled Mometasone Furoate/Formoterol Fixed-Dose Combination Formulation Compared With Formoterol and High-Dose Inhaled Mometasone Furoate Monotherapy in Subjects With Moderate to Severe COPD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,196 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC\[0-12hr\]) and change from Baseline to Week 13 in AM predose FEV1.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Mometasone furoate/formoterol (MF/F) combination	MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
DRUG	Mometasone furoate/formoterol (MF/F) combination	MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks
DRUG	Mometasone furoate MDI (MF MDI)	MF 400 mcg via metered dose inhaler twice daily for 52 weeks
DRUG	Formoterol MDI	Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks
DRUG	Placebo	Placebo MDI twice a day for 26 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2006-10-03
• Last updated: 2024-05-23
• Results posted: 2011-10-26