Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1055
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None

Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI) intervention 4: Formoterol MDI intervention 5: Placebo
Intervention descriptions: intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 52 weeks intervention 4: Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks intervention 5: Placebo MDI twice a day for 26 weeks

Protocol document: