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: 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
B: 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
C: Arm Label: Umeclidinium/Vilanterol; Type: EXPERIMENTAL; Interventions: Drug: Umeclidinium/Vilanterol 62.5/25 mcg | Arm Label: Tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium 18 mcg | Intervention Type: DRUG; Name: Umeclidinium/Vilanterol 62.5/25 mcg; Assigned to Arm(s): Umeclidinium/Vilanterol | Intervention Type: DRUG; Name: Tiotropium 18 mcg; Assigned to Arm(s): Tiotropium
D: Arm Label: QVA149; Type: EXPERIMENTAL; Interventions: Drug: indacaterol and glycopyrronium (QVA149), Drug: Placebo to fluticasone/salmeterol | Arm Label: fluticasone/salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: fluticasone/salmeterol, Drug: Placebo to indacaterol and glycopyrronium (QVA149) | Intervention Type: DRUG; Name: indacaterol and glycopyrronium (QVA149); Assigned to Arm(s): QVA149 | Intervention Type: DRUG; Name: Placebo to fluticasone/salmeterol; Assigned to Arm(s): QVA149 | Intervention Type: DRUG; Name: fluticasone/salmeterol; Assigned to Arm(s): fluticasone/salmeterol | Intervention Type: DRUG; Name: Placebo to indacaterol and glycopyrronium (QVA149); Assigned to Arm(s): fluticasone/salmeterol

Answer: A