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: tiotropium + olodaterol low dose; Type: EXPERIMENTAL; Interventions: Drug: olodaterol, Drug: tiotropium | Arm Label: tiotropium + olodaterol high dose; Type: EXPERIMENTAL; Interventions: Drug: olodaterol, Drug: tiotropium | Arm Label: tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: tiotropium | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: olodaterol; Assigned to Arm(s): tiotropium + olodaterol high dose, tiotropium + olodaterol low dose | Intervention Type: DRUG; Name: tiotropium; Assigned to Arm(s): tiotropium, tiotropium + olodaterol high dose, tiotropium + olodaterol low dose | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
B: Arm Label: GFF MDI (PT003); Type: EXPERIMENTAL; Interventions: Drug: GFF MDI (PT003) | Arm Label: Placebo MDI; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo MDI | Intervention Type: DRUG; Name: GFF MDI (PT003); Assigned to Arm(s): GFF MDI (PT003) | Intervention Type: DRUG; Name: Placebo MDI; Assigned to Arm(s): Placebo MDI
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: 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
D: Arm Label: olodaterol (BI 1744) low and placebo; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) low, Drug: Placebo, Device: Respimat | Arm Label: olodaterol (BI 1744) low and low tio; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) low, Drug: low tiotropium bromide, Device: Respimat | Arm Label: olodaterol (BI 1744) low and medium tio; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) low, Drug: medium tiotropium bromide, Device: Respimat | Arm Label: olodaterol (BI 1744) low and high tio; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) low, Drug: high tiotropium bromide, Device: Respimat | Arm Label: olodaterol (BI 1744) high and placebo; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) high, Drug: Placebo, Device: Respimat | Arm Label: Olodaterol (BI 1744) high and low tio; Type: EXPERIMENTAL; Interventions: Drug: low tiotropium bromide, Drug: olodaterol (BI 1744) high, Device: Respimat | Arm Label: Olodaterol (BI 1744) high and medium tio; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) high, Drug: medium tiotropium bromide, Device: Respimat | Arm Label: Olodaterol (BI 1744) high and high tio; Type: EXPERIMENTAL; Interventions: Drug: olodaterol (BI 1744) high, Drug: high tiotropium bromide, Device: Respimat | Intervention Type: DRUG; Name: olodaterol (BI 1744) low; Assigned to Arm(s): olodaterol (BI 1744) low and high tio, olodaterol (BI 1744) low and low tio, olodaterol (BI 1744) low and medium tio, olodaterol (BI 1744) low and placebo | Intervention Type: DRUG; Name: low tiotropium bromide; Assigned to Arm(s): Olodaterol (BI 1744) high and low tio, olodaterol (BI 1744) low and low tio | Intervention Type: DRUG; Name: olodaterol (BI 1744) high; Assigned to Arm(s): Olodaterol (BI 1744) high and high tio, Olodaterol (BI 1744) high and low tio, Olodaterol (BI 1744) high and medium tio, olodaterol (BI 1744) high and placebo | Intervention Type: DRUG; Name: medium tiotropium bromide; Assigned to Arm(s): Olodaterol (BI 1744) high and medium tio, olodaterol (BI 1744) low and medium tio | Intervention Type: DRUG; Name: high tiotropium bromide; Assigned to Arm(s): Olodaterol (BI 1744) high and high tio, olodaterol (BI 1744) low and high tio | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): olodaterol (BI 1744) high and placebo, olodaterol (BI 1744) low and placebo | Intervention Type: DEVICE; Name: Respimat; Assigned to Arm(s): Olodaterol (BI 1744) high and high tio, Olodaterol (BI 1744) high and low tio, Olodaterol (BI 1744) high and medium tio, olodaterol (BI 1744) high and placebo, olodaterol (BI 1744) low and high tio, olodaterol (BI 1744) low and low tio, olodaterol (BI 1744) low and medium tio, olodaterol (BI 1744) low and placebo

Answer: C