Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: DB2116134: A Randomized, Multi-center, Double-blind, Double-dummy, Parallel Group Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With COPD
Brief Summary: This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with Chronic Obstructive Pulmonary Disease (COPD). Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 500/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.


Options:
A: Arm Label: GSK573719/GW642444; Type: EXPERIMENTAL; Interventions: Drug: GSK573719/GW642444 125/25mcg | Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 125mcg | Arm Label: GW642444; Type: EXPERIMENTAL; Interventions: Drug: GW642444 25mcg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo only | Intervention Type: DRUG; Name: GSK573719/GW642444 125/25mcg; Assigned to Arm(s): GSK573719/GW642444 | Intervention Type: DRUG; Name: GSK573719 125mcg; Assigned to Arm(s): GSK573719 | Intervention Type: DRUG; Name: GW642444 25mcg; Assigned to Arm(s): GW642444 | Intervention Type: DRUG; Name: Placebo only; Assigned to Arm(s): Placebo
B: Intervention Type: DRUG; Name: Test: Tiotropium 18 µg per day (one inhalation capsule) plus 12 µg formoterol twice daily (two times one inhalation capsule); Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: Reference: Salmeterol MDI 50 µg (2 puffs of 25 µg each) b.i.d., plus fluticasone propionate MDI 500 µg (2 puffs of 250 µg each) b.i.d.; Assigned to Arm(s): N/A
C: Arm Label: Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium bromide/Vilanterol, Drug: Placebo ACCUHALER/DISKUS | Arm Label: Fluticasone propionate/Salmeterol + placebo NDPI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/Salmeterol, Drug: Placebo NDPI | Intervention Type: DRUG; Name: Umeclidinium bromide/Vilanterol; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Placebo ACCUHALER/DISKUS; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Fluticasone propionate/Salmeterol; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI | Intervention Type: DRUG; Name: Placebo NDPI; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI
D: Arm Label: Umeclidinium/vilanterol Arm; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium/vilanterol, Drug: Placebo | Arm Label: Fluticasone propionate/salmeterol Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/salmeterol, Drug: Placebo | Intervention Type: DRUG; Name: Umeclidinium/vilanterol; Assigned to Arm(s): Umeclidinium/vilanterol Arm | Intervention Type: DRUG; Name: Fluticasone propionate/salmeterol; Assigned to Arm(s): Fluticasone propionate/salmeterol Arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Fluticasone propionate/salmeterol Arm, Umeclidinium/vilanterol Arm

Answer: C