Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
Brief Summary: This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Aclidinium bromide | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Aclidinium bromide; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Aclidinium bromide; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3
B: Arm Label: NVA237; Type: EXPERIMENTAL; Interventions: Drug: NVA237, Drug: Placebo to tiotropium, Drug: salbutamol/albuterol | Arm Label: Tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium, Drug: Placebo to NVA237 | Intervention Type: DRUG; Name: NVA237; Assigned to Arm(s): NVA237 | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Tiotropium | Intervention Type: DRUG; Name: Placebo to tiotropium; Assigned to Arm(s): NVA237 | Intervention Type: DRUG; Name: Placebo to NVA237; Assigned to Arm(s): Tiotropium | Intervention Type: DRUG; Name: salbutamol/albuterol; Assigned to Arm(s): NVA237
C: Arm Label: GFF MDI (PT003); Type: EXPERIMENTAL; Interventions: Drug: GFF MDI (PT 003) | Arm Label: GP MDI (PT001); Type: EXPERIMENTAL; Interventions: Drug: GP MDI (PT001) | Arm Label: FF MDI (PT005); Type: EXPERIMENTAL; Interventions: Drug: FF MDI (PT005) | Arm Label: Open-label tiotropium bromide inhalation powder; Type: ACTIVE_COMPARATOR; Interventions: Drug: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®) | Intervention Type: DRUG; Name: GFF MDI (PT 003); Assigned to Arm(s): GFF MDI (PT003) | Intervention Type: DRUG; Name: GP MDI (PT001); Assigned to Arm(s): GP MDI (PT001) | Intervention Type: DRUG; Name: FF MDI (PT005); Assigned to Arm(s): FF MDI (PT005) | Intervention Type: DRUG; Name: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®); Assigned to Arm(s): Open-label tiotropium bromide inhalation powder
D: Arm Label: FF/GW642444 Inhalation Powder 100/25 mcg QD; Type: EXPERIMENTAL; Interventions: Drug: FF/GW642444 Inhalation Powder | Arm Label: FF/GW642444 Inhalation Powder 200/25 mcg QD; Type: EXPERIMENTAL; Interventions: Drug: FF/GW642444 Inhalation Powder | Arm Label: FF/GW642444 Inhalation Powder 50mcg/25mcg QD; Type: EXPERIMENTAL; Interventions: Drug: FF/GW642444 Inhalation Powder | Arm Label: GW642444 25mcg QD; Type: EXPERIMENTAL; Interventions: Drug: GW642444 Inhalation Powder | Intervention Type: DRUG; Name: FF/GW642444 Inhalation Powder; Assigned to Arm(s): FF/GW642444 Inhalation Powder 100/25 mcg QD, FF/GW642444 Inhalation Powder 200/25 mcg QD, FF/GW642444 Inhalation Powder 50mcg/25mcg QD | Intervention Type: DRUG; Name: GW642444 Inhalation Powder; Assigned to Arm(s): GW642444 25mcg QD

Answer: C