Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-center Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GSK573719 and With Tiotropium Over 24 Weeks in Subjects With COPD
Brief Summary: This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 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 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.


Options:
A: Arm Label: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 | Intervention Type: DRUG; Name: GSK573719; Assigned to Arm(s): GSK573719
B: 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: GSK573719; Type: EXPERIMENTAL; Interventions: Drug: GSK573719 | 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: GSK573719; Assigned to Arm(s): GSK573719 | Intervention Type: DRUG; Name: tiotropium bromide; Assigned to Arm(s): tiotropium bromide
C: 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
D: Arm Label: Umeclidinium 62.5 mcg; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium | Arm Label: Glycopyrronium 44 mcg; Type: EXPERIMENTAL; Interventions: Drug: Glycopyrronium | Intervention Type: DRUG; Name: Umeclidinium; Assigned to Arm(s): Umeclidinium 62.5 mcg | Intervention Type: DRUG; Name: Glycopyrronium; Assigned to Arm(s): Glycopyrronium 44 mcg

Answer: B