Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
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.


Options:
A: Intervention Type: DRUG; Name: Salmeterol 50mcg/ Fluticasone Propionate 500mcg; Assigned to Arm(s): N/A
B: Arm Label: MF/F MDI 400/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) combination | Arm Label: MF/F MDI 200/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) combination | Arm Label: MF MDI 400 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate MDI (MF MDI) | Arm Label: Formoterol MDI 10 mcg BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol MDI | Arm Label: Placebo MDI BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) combination; Assigned to Arm(s): MF/F MDI 400/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) combination; Assigned to Arm(s): MF/F MDI 200/10 mcg BID | Intervention Type: DRUG; Name: Mometasone furoate MDI (MF MDI); Assigned to Arm(s): MF MDI 400 mcg BID | Intervention Type: DRUG; Name: Formoterol MDI; Assigned to Arm(s): Formoterol MDI 10 mcg BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo MDI BID
C: Arm Label: Indacaterol 300 μg plus placebo to formoterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to formoterol | Arm Label: Indacaterol 600 μg plus placebo to formoterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to formoterol | Arm Label: Formoterol 12 μg plus placebo to indacaterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol, Drug: Placebo to indacaterol | Arm Label: Placebo to indacaterol plus placebo to formoterol; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to indacaterol, Drug: Placebo to formoterol | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol | Intervention Type: DRUG; Name: Formoterol; Assigned to Arm(s): Formoterol 12 μg plus placebo to indacaterol | Intervention Type: DRUG; Name: Placebo to indacaterol; Assigned to Arm(s): Formoterol 12 μg plus placebo to indacaterol, Placebo to indacaterol plus placebo to formoterol | Intervention Type: DRUG; Name: Placebo to formoterol; Assigned to Arm(s): Indacaterol 300 μg plus placebo to formoterol, Indacaterol 600 μg plus placebo to formoterol, Placebo to indacaterol plus placebo to formoterol
D: Intervention Type: DRUG; Name: Budesonide/formoterol pMDI; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Budesonide pMDI; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Formoterol Turbuhaler; Assigned to Arm(s): N/A

Answer: B