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: Sequence 1; Type: EXPERIMENTAL; Interventions: Drug: FF 400 mcg, Drug: UMEC 500 mcg, Drug: UMEC 250 mcg, Drug: VI 100 mcg | Arm Label: Sequence 2; Type: EXPERIMENTAL; Interventions: Drug: FF 400 mcg, Drug: UMEC 500 mcg, Drug: UMEC 250 mcg, Drug: VI 100 mcg | Arm Label: Sequence 3; Type: EXPERIMENTAL; Interventions: Drug: FF 400 mcg, Drug: UMEC 500 mcg, Drug: UMEC 250 mcg, Drug: VI 100 mcg | Arm Label: Sequence 4; Type: EXPERIMENTAL; Interventions: Drug: FF 400 mcg, Drug: UMEC 500 mcg, Drug: UMEC 250 mcg, Drug: VI 100 mcg | Intervention Type: DRUG; Name: FF 400 mcg; Assigned to Arm(s): Sequence 1, Sequence 2, Sequence 3, Sequence 4 | Intervention Type: DRUG; Name: UMEC 500 mcg; Assigned to Arm(s): Sequence 1, Sequence 2, Sequence 3, Sequence 4 | Intervention Type: DRUG; Name: UMEC 250 mcg; Assigned to Arm(s): Sequence 1, Sequence 2, Sequence 3, Sequence 4 | Intervention Type: DRUG; Name: VI 100 mcg; Assigned to Arm(s): Sequence 1, Sequence 2, Sequence 3, Sequence 4
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: 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: Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719 | Arm Label: Seq 3: UMEC 250 µg, placebo, UMEC 500 µg, UMEC 1000 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719 | Arm Label: Seq 4: UMEC 250 µg, UMEC 500 µg, placebo, UMEC 1000 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719 | Arm Label: Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719 | Arm Label: Seq 6: UMEC 250 µg, placebo, Tiotropium 18 µg, UMEC 500 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 8: Tiotropium 18 µg, placebo, UMEC 250 µg, UMEC 500 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 10: Tiotropium 18 µg, UMEC 250 µg, placebo, UMEC 500 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Arm Label: Seq 12: UMEC 250 µg, placebo, UMEC 500 µg, Tiotropium 18 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: GSK573719, Drug: Tiotropium | Intervention Type: DRUG; Name: GSK573719; Assigned to Arm(s): Seq 10: Tiotropium 18 µg, UMEC 250 µg, placebo, UMEC 500 µg, Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg, Seq 12: UMEC 250 µg, placebo, UMEC 500 µg, Tiotropium 18 µg, Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, placebo, Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, placebo, Seq 3: UMEC 250 µg, placebo, UMEC 500 µg, UMEC 1000 µg, Seq 4: UMEC 250 µg, UMEC 500 µg, placebo, UMEC 1000 µg, Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, Seq 6: UMEC 250 µg, placebo, Tiotropium 18 µg, UMEC 500 µg, Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Seq 8: Tiotropium 18 µg, placebo, UMEC 250 µg, UMEC 500 µg, Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, placebo | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Seq 10: Tiotropium 18 µg, UMEC 250 µg, placebo, UMEC 500 µg, Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg, Seq 12: UMEC 250 µg, placebo, UMEC 500 µg, Tiotropium 18 µg, Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, placebo, Seq 6: UMEC 250 µg, placebo, Tiotropium 18 µg, UMEC 500 µg, Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Seq 8: Tiotropium 18 µg, placebo, UMEC 250 µg, UMEC 500 µg, Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, placebo

Answer: B