Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Brief Summary: This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).


Options:
A: Arm Label: FF/VI 100/25 mcg + UMEC (62.5mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + UMEC (125mcg); Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: UMEC | Arm Label: FF/VI 100/25 mcg + Placebo; Type: EXPERIMENTAL; Interventions: Drug: FF, Drug: VI, Drug: Placebo | Intervention Type: DRUG; Name: FF; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: VI; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo, FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: UMEC; Assigned to Arm(s): FF/VI 100/25 mcg + UMEC (125mcg), FF/VI 100/25 mcg + UMEC (62.5mcg) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): FF/VI 100/25 mcg + Placebo
B: Arm Label: GSK573719/GW642444; Type: EXPERIMENTAL; Interventions: Drug: 62.5/25mcg | Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: 62.5mcg | Arm Label: GW642444; Type: EXPERIMENTAL; Interventions: Drug: 25mcg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: 62.5/25mcg; Assigned to Arm(s): GSK573719/GW642444 | Intervention Type: DRUG; Name: 62.5mcg; Assigned to Arm(s): GSK573719 | Intervention Type: DRUG; Name: 25mcg; Assigned to Arm(s): GW642444 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 | Intervention Type: DRUG; Name: GSK573719; Assigned to Arm(s): GSK573719
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: B