Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter Trial Comparing the Efficacy and Safety of GSK573719/GW642444 With GW642444 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 and GW642444 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/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
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: 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
C: Arm Label: Indacaterol 150 µg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 150 μg, Drug: Placebo to tiotropium | Arm Label: Tiotropium 18 µg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium 18 μg, Drug: Placebo to indacaterol | Intervention Type: DRUG; Name: Indacaterol 150 μg; Assigned to Arm(s): Indacaterol 150 µg | Intervention Type: DRUG; Name: Tiotropium 18 μg; Assigned to Arm(s): Tiotropium 18 µg | Intervention Type: DRUG; Name: Placebo to indacaterol; Assigned to Arm(s): Tiotropium 18 µg | Intervention Type: DRUG; Name: Placebo to tiotropium; Assigned to Arm(s): Indacaterol 150 µg
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium Bromide/Formoterol Fumarate | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aclidinium Bromide | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol Fumarate | Arm Label: 5; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium Bromide/Formoterol Fumarate; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aclidinium Bromide/Formoterol Fumarate; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Aclidinium Bromide; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: Formoterol Fumarate; Assigned to Arm(s): 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 5

Answer: B