Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Blinded, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Umeclidinium (UMEC) 62.5 mcg Compared With Tiotropium 18 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief Summary: This is a multicentre, randomized, blinded, double dummy, parallel group study to evaluate the efficacy and safety of UMEC inhalation powder\[ (62.5 microgram (mcg) once daily (QD)\] when administered via a novel Dry Powder Inhaler compared with tiotropium (18 mcg QD) administered via a HANDIHALER® inhaler over a treatment period of 12 weeks (24 weeks in Germany) in subjects with chronic obstructive pulmonary disease (COPD). At the end of the run-in period, subjects who meet the randomization criteria will be randomized to receive UMEC 62.5 mcg administered via novel dry powder inhaler(nDPI) + Placebo administered via HANDIHALER inhaler OR Tiotropium 18 mcg administered via HANDIHALER inhaler + Placebo administered via nDPI in a 1:1 ratio. There will be up to 8 clinic visits conducted on an outpatient basis at Pre-Screening (Visit 0), Screening (Visit 1), a 7 to 14 day run-in period, randomization at Day 1 (Visit 2), and after randomization at Day 2 (Visit 3), Day 28 (Visit 4), Day 56 (Visit 5), Day 84 (Visit 6) and Day 85 (Visit 7). For subjects enrolled in Germany, there will be an additional 3 visits at Day 112 (Visit 8), Day 140 (Visit 9) and Day 168 (Visit 10). The total duration of subject participation in the study will be approximately 15 weeks (27 weeks in Germany). The primary endpoint of the study is clinic visit trough forced expiratory volume in one second (FEV1) on treatment Day 85. All subjects will have spirometry performed at clinic Visits 1 though 7. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 7.

HANDIHALER is a registered trademark of Boehringer Ingelheim Pharma GmbH \& Co. KG.


Options:
A: Arm Label: tiotropium + olodaterol low dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium, Drug: olodaterol | Arm Label: tiotropium + olodaterol high dose; Type: EXPERIMENTAL; Interventions: Drug: tiotropium, Drug: olodaterol | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium + olodaterol low dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol low dose
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: 1; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium bromide; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aclidinium bromide; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3
D: Arm Label: Umeclidinium 62.5 mcg + placebo; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium, Drug: Umeclidinium matching placebo | Arm Label: Tiotropium 18mcg + placebo; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Tiotropium matching placebo | Intervention Type: DRUG; Name: Umeclidinium; Assigned to Arm(s): Umeclidinium 62.5 mcg + placebo | Intervention Type: DRUG; Name: Umeclidinium matching placebo; Assigned to Arm(s): Umeclidinium 62.5 mcg + placebo | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium 18mcg + placebo | Intervention Type: DRUG; Name: Tiotropium matching placebo; Assigned to Arm(s): Tiotropium 18mcg + placebo

Answer: D