Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD
Brief Summary: This is a Phase IIIb multicentre, randomised, blinded, triple dummy, parallel group study to evaluate the efficacy and safety of UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] Once daily \[QD\]) when administered via ELLIPTA® Dry Powder Inhaler (DPI) compared to indacaterol plus tiotropium (150 mcg/18 mcg respectively QD) administered via individual inhalers over a treatment period of 12 weeks in participants with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The purpose of this study is to demonstrate that UMEC/VI (delivered via ELLIPTA DPI), when used in symptomatic moderate to very severe COPD participants, is non-inferior to the combination of indacaterol (delivered via BREEZHALER® inhaler) plus tiotropium (delivered via HANDIHALER® inhaler) on measures of trough forced expiratory volume in one second (FEV1) after 12 weeks of treatment. Participants who met the eligibility criteria at screening (Visit 1) will complete a 5 to 7 day run in period prior to randomisation at Visit 2. Clinic visits will follow at day 2, week 2, week 4, week 8 and week 12 of treatment, plus week 12 + 1 day (Visits 3 to 8). The total duration of study participation will be approximately 14 weeks. ELLIPTA is a registered trademark of the GSK group of companies. HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG. BREEZHALER is a registered trademark of Novartis AG.


Options:
A: Arm Label: Indacaterol; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 150 µg | Arm Label: Tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium | Intervention Type: DRUG; Name: Indacaterol 150 µg; Assigned to Arm(s): Indacaterol | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium
B: Arm Label: UMEC/VI arm; Type: EXPERIMENTAL; Interventions: Drug: UMEC/VI, Drug: UMEC/VI matching placebo, Drug: Albuterol/salbutamol Metered Dose Inhaler (MDI) | Arm Label: Tiotropium + Indacaterol arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Tiotropium matching placebo, Drug: Indacaterol, Drug: Indacaterol matching placebo, Drug: Albuterol/salbutamol Metered Dose Inhaler (MDI) | Intervention Type: DRUG; Name: UMEC/VI; Assigned to Arm(s): UMEC/VI arm | Intervention Type: DRUG; Name: UMEC/VI matching placebo; Assigned to Arm(s): UMEC/VI arm | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Tiotropium matching placebo; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Indacaterol matching placebo; Assigned to Arm(s): Tiotropium + Indacaterol arm | Intervention Type: DRUG; Name: Albuterol/salbutamol Metered Dose Inhaler (MDI); Assigned to Arm(s): Tiotropium + Indacaterol arm, UMEC/VI arm
C: Arm Label: GSK573719/GW642444 125/25; Type: EXPERIMENTAL; Interventions: Drug: GSK573719/GW642444 125/25 | Arm Label: GSK573719/GW642444 62.5/25; Type: EXPERIMENTAL; Interventions: Drug: GSK573719/GW642444 62.5/25 | Arm Label: GW642444; Type: EXPERIMENTAL; Interventions: Drug: GW642444 | Arm Label: tiotropium bromide; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium bromide | Intervention Type: DRUG; Name: GSK573719/GW642444 125/25; Assigned to Arm(s): GSK573719/GW642444 125/25 | Intervention Type: DRUG; Name: GSK573719/GW642444 62.5/25; Assigned to Arm(s): GSK573719/GW642444 62.5/25 | Intervention Type: DRUG; Name: GW642444; Assigned to Arm(s): GW642444 | Intervention Type: DRUG; Name: tiotropium bromide; Assigned to Arm(s): tiotropium bromide
D: Arm Label: Indacaterol 150 µg (Continued Into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Indacaterol 300 µg (Continued Into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Tiotropium 18 µg (Continued Into Stage 2); Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium (18 µg o.d.) | Arm Label: Placebo (Continued Into Stage 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Indacaterol 75 µg (Not Continued into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Indacaterol, Drug: Placebo to Formoterol | Arm Label: Indacaterol 600 µg (Not Continued Into Stage 2); Type: EXPERIMENTAL; Interventions: Drug: Indacaterol, Drug: Placebo to Formoterol | Arm Label: Formoterol 12 µg (Not Continued Into Stage 2); Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol (12 µg b.i.d.), Drug: Placebo to Indacaterol | Intervention Type: DRUG; Name: Indacaterol; Assigned to Arm(s): Indacaterol 150 µg (Continued Into Stage 2), Indacaterol 300 µg (Continued Into Stage 2), Indacaterol 600 µg (Not Continued Into Stage 2), Indacaterol 75 µg (Not Continued into Stage 2) | Intervention Type: DRUG; Name: Formoterol (12 µg b.i.d.); Assigned to Arm(s): Formoterol 12 µg (Not Continued Into Stage 2) | Intervention Type: DRUG; Name: Tiotropium (18 µg o.d.); Assigned to Arm(s): Tiotropium 18 µg (Continued Into Stage 2) | Intervention Type: DRUG; Name: Placebo to Indacaterol; Assigned to Arm(s): Formoterol 12 µg (Not Continued Into Stage 2), Indacaterol 150 µg (Continued Into Stage 2), Indacaterol 300 µg (Continued Into Stage 2), Indacaterol 75 µg (Not Continued into Stage 2), Placebo (Continued Into Stage 2) | Intervention Type: DRUG; Name: Placebo to Formoterol; Assigned to Arm(s): Indacaterol 150 µg (Continued Into Stage 2), Indacaterol 300 µg (Continued Into Stage 2), Indacaterol 600 µg (Not Continued Into Stage 2), Indacaterol 75 µg (Not Continued into Stage 2), Placebo (Continued Into Stage 2)

Answer: B