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: Olodaterol (BI 1744) Low; Type: EXPERIMENTAL; Interventions: Drug: Olodaterol (BI 1744) | Arm Label: Olodaterol (BI 1744) High; Type: EXPERIMENTAL; Interventions: Drug: Olodaterol (BI 1744) | Arm Label: Formoterol 12mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Formoterol | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Olodaterol (BI 1744); Assigned to Arm(s): Olodaterol (BI 1744) Low | Intervention Type: DRUG; Name: Olodaterol (BI 1744); Assigned to Arm(s): Olodaterol (BI 1744) High | Intervention Type: DRUG; Name: Formoterol; Assigned to Arm(s): Formoterol 12mcg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
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: arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination | Arm Label: arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers | Intervention Type: DRUG; Name: Salmeterol / Fluticasone (50/500 µg) BID fixed combination; Assigned to Arm(s): arm 1 | Intervention Type: DRUG; Name: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers; Assigned to Arm(s): arm 2
D: Arm Label: QVA149; Type: EXPERIMENTAL; Interventions: Drug: QVA149, Drug: Salbutamol/albuterol | Arm Label: NVA237; Type: ACTIVE_COMPARATOR; Interventions: Drug: NVA237, Drug: Salbutamol/albuterol | Arm Label: open-label tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium, Drug: Salbutamol/albuterol | Intervention Type: DRUG; Name: QVA149; Assigned to Arm(s): QVA149 | Intervention Type: DRUG; Name: NVA237; Assigned to Arm(s): NVA237 | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): open-label tiotropium | Intervention Type: DRUG; Name: Salbutamol/albuterol; Assigned to Arm(s): NVA237, QVA149, open-label tiotropium

Answer: B