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: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo to tiotropium + olodaterol | Arm Label: tiotropium + olodaterol high dose with BM; Type: EXPERIMENTAL; Interventions: Drug: tiotropium +olodaterol | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Arm Label: tiotropium + olodaterol with exercise training and BM; Type: EXPERIMENTAL; Interventions: Drug: tiotropium+olodaterol | Intervention Type: DRUG; Name: placebo to tiotropium + olodaterol; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: tiotropium+olodaterol; Assigned to Arm(s): tiotropium + olodaterol with exercise training and BM | Intervention Type: DRUG; Name: tiotropium +olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose with BM | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium
B: Arm Label: tiotropium+olodaterol low dose FDC; Type: EXPERIMENTAL; Interventions: Drug: tiotropium + olodaterol, Device: Respimat | Arm Label: tiotropium+olodaterol high dose FDC; Type: EXPERIMENTAL; Interventions: Drug: tiotropium + olodaterol, Device: Respimat | Arm Label: olodaterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: olodaterol, Device: Respimat | Arm Label: tiotropium low dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium, Device: Respimat | Arm Label: tiotropium high dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium, Device: Respimat | Intervention Type: DRUG; Name: tiotropium + olodaterol; Assigned to Arm(s): tiotropium+olodaterol low dose FDC | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium low dose | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): olodaterol | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium high dose | Intervention Type: DRUG; Name: tiotropium + olodaterol; Assigned to Arm(s): tiotropium+olodaterol high dose FDC | Intervention Type: DEVICE; Name: Respimat; Assigned to Arm(s): olodaterol, tiotropium high dose, tiotropium low dose, tiotropium+olodaterol high dose FDC, tiotropium+olodaterol low dose FDC
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: GFF MDI; Type: EXPERIMENTAL; Interventions: Drug: GFF MDI | Arm Label: GP MDI; Type: EXPERIMENTAL; Interventions: Drug: GP MDI | Arm Label: FF MDI; Type: EXPERIMENTAL; Interventions: Drug: FF MDI | Arm Label: Open-label tiotropium bromide inhalation powder; Type: ACTIVE_COMPARATOR; Interventions: Drug: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo MDI | Intervention Type: DRUG; Name: GFF MDI; Assigned to Arm(s): GFF MDI | Intervention Type: DRUG; Name: GP MDI; Assigned to Arm(s): GP MDI | Intervention Type: DRUG; Name: FF MDI; Assigned to Arm(s): FF MDI | Intervention Type: DRUG; Name: Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®); Assigned to Arm(s): Open-label tiotropium bromide inhalation powder | Intervention Type: DRUG; Name: Placebo MDI; Assigned to Arm(s): Placebo

Answer: C