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: 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
B: 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
C: Arm Label: UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm; Type: EXPERIMENTAL; Interventions: Drug: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI, Drug: Placebo DISKUS | Arm Label: FSC via ACCUHALER/DISKUS + placebo NDPI arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS, Drug: Placebo NDPI | Intervention Type: DRUG; Name: UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI; Assigned to Arm(s): UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm | Intervention Type: DRUG; Name: FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS; Assigned to Arm(s): FSC via ACCUHALER/DISKUS + placebo NDPI arm | Intervention Type: DRUG; Name: Placebo DISKUS; Assigned to Arm(s): UMEC/ VI via NDPI + placebo ACCUHALER/DISKUS arm | Intervention Type: DRUG; Name: Placebo NDPI; Assigned to Arm(s): FSC via ACCUHALER/DISKUS + placebo NDPI arm
D: Arm Label: A1 (any SABA and/or SAMA); Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium, Drug: SABA, Drug: SAMA | Arm Label: A2 (glycopyrronium); Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium, Drug: SABA, Drug: LABA, Drug: SAMA | Arm Label: B1 (any LAMA or LABA and mMRC=1); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: Indacaterol maleate and glycopyrronium bromide, Drug: LAMA, Drug: ICS | Arm Label: B2 (glycopyrronium and mMRC=1); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: Indacaterol maleate and glycopyrronium bromide, Drug: LAMA | Arm Label: C1 (any LABA and ICS); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: ICS | Arm Label: C2 (indacaterol/glycopyrronium); Type: EXPERIMENTAL; Interventions: Drug: LABA, Drug: ICS | Arm Label: D1 (any LAMA or LABA and mMRC>1); Type: EXPERIMENTAL; Interventions: Drug: LAMA | Arm Label: D2 (indacaterol/glycopyrronium and mMRC>1); Type: EXPERIMENTAL; Interventions: Drug: LAMA | Intervention Type: DRUG; Name: Glycopyrronium; Assigned to Arm(s): A1 (any SABA and/or SAMA), A2 (glycopyrronium) | Intervention Type: DRUG; Name: SABA; Assigned to Arm(s): A1 (any SABA and/or SAMA), A2 (glycopyrronium) | Intervention Type: DRUG; Name: LABA; Assigned to Arm(s): A2 (glycopyrronium), B1 (any LAMA or LABA and mMRC=1), B2 (glycopyrronium and mMRC=1), C1 (any LABA and ICS), C2 (indacaterol/glycopyrronium) | Intervention Type: DRUG; Name: Indacaterol maleate and glycopyrronium bromide; Assigned to Arm(s): B1 (any LAMA or LABA and mMRC=1), B2 (glycopyrronium and mMRC=1) | Intervention Type: DRUG; Name: LAMA; Assigned to Arm(s): B1 (any LAMA or LABA and mMRC=1), B2 (glycopyrronium and mMRC=1), D1 (any LAMA or LABA and mMRC>1), D2 (indacaterol/glycopyrronium and mMRC>1) | Intervention Type: DRUG; Name: SAMA; Assigned to Arm(s): A1 (any SABA and/or SAMA), A2 (glycopyrronium) | Intervention Type: DRUG; Name: ICS; Assigned to Arm(s): B1 (any LAMA or LABA and mMRC=1), C1 (any LABA and ICS), C2 (indacaterol/glycopyrronium)

Answer: A