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: 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
B: Arm Label: Umeclidinium/Vilanterol; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium/Vilanterol 62.5/25 mcg | Arm Label: Tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium 18 mcg | Intervention Type: DRUG; Name: Umeclidinium/Vilanterol 62.5/25 mcg; Assigned to Arm(s): Umeclidinium/Vilanterol | Intervention Type: DRUG; Name: Tiotropium 18 mcg; Assigned to Arm(s): Tiotropium
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: GSK573719/GW642444; Type: EXPERIMENTAL; Interventions: Drug: GSK573719/GW642444 125/25mcg | Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 125mcg | Arm Label: GW642444; Type: EXPERIMENTAL; Interventions: Drug: GW642444 25mcg | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo only | Intervention Type: DRUG; Name: GSK573719/GW642444 125/25mcg; Assigned to Arm(s): GSK573719/GW642444 | Intervention Type: DRUG; Name: GSK573719 125mcg; Assigned to Arm(s): GSK573719 | Intervention Type: DRUG; Name: GW642444 25mcg; Assigned to Arm(s): GW642444 | Intervention Type: DRUG; Name: Placebo only; Assigned to Arm(s): Placebo

Answer: D