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: Aclidinium bromide 200 μg bid; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide 200 μg bid | Arm Label: Aclidininum bromide 400 μg bid; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide 400 μg bid | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium bromide 200 μg bid; Assigned to Arm(s): Aclidinium bromide 200 μg bid | Intervention Type: DRUG; Name: Aclidinium bromide 400 μg bid; Assigned to Arm(s): Aclidininum bromide 400 μg bid | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium bromide/Vilanterol, Drug: Placebo ACCUHALER/DISKUS | Arm Label: Fluticasone propionate/Salmeterol + placebo NDPI; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/Salmeterol, Drug: Placebo NDPI | Intervention Type: DRUG; Name: Umeclidinium bromide/Vilanterol; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Placebo ACCUHALER/DISKUS; Assigned to Arm(s): Umeclidinium bromide/Vilanterol + placebo ACCUHALER/DISKUS | Intervention Type: DRUG; Name: Fluticasone propionate/Salmeterol; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI | Intervention Type: DRUG; Name: Placebo NDPI; Assigned to Arm(s): Fluticasone propionate/Salmeterol + placebo NDPI
C: Arm Label: Indacaterol 150 μg and tiotropium 18 μg; Type: EXPERIMENTAL; Interventions: Drug: Indacaterol 150 μg, Drug: Tiotropium 18 μg | 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 and tiotropium 18 μg | Intervention Type: DRUG; Name: Tiotropium 18 μg; Assigned to Arm(s): Indacaterol 150 μg and tiotropium 18 μg, Tiotropium 18 μg | Intervention Type: DRUG; Name: Placebo to indacaterol; Assigned to Arm(s): Tiotropium 18 μg
D: 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

Answer: D