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: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Budesonide/formoterol (Symbicort Turbuhaler) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol (Oxis Turbuhaler) | Intervention Type: DRUG; Name: Budesonide/formoterol (Symbicort Turbuhaler); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Formoterol (Oxis Turbuhaler); Assigned to Arm(s): 2
B: Intervention Type: DEVICE; Name: Pulmonary function Testing; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: tiotropium bromide; Assigned to Arm(s): N/A
C: Intervention Type: DEVICE; Name: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler; Assigned to Arm(s): N/A | Intervention Type: DEVICE; Name: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler; Assigned to Arm(s): N/A
D: 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

Answer: D