Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma
Brief Summary: The trial is a randomised, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of 5 µg tiotropium over a 48-week treatment period as compared to placebo. Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined as add-on controller therapy on top of usual care in patients with severe persistent asthma.

The primary objective of each trial is to evaluate the long term efficacy of tiotropium over placebo on top of usual care in patients with severe persistent asthma as determined by pulmonary function testing, effects on asthma exacerbations, effects on quality of life, on asthma control and health care resource utilisation. The secondary objective of each trial is to compare the long term safety of tiotropium with placebo in this patient population.


Options:
A: Arm Label: Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI, Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: Metered Dose Inhaler, Device: Connected Inhaler System | Arm Label: Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS; Type: EXPERIMENTAL; Interventions: Drug: FF/UMEC/VI, Drug: Albuterol/salbutamol, Device: ELLIPTA DPI, Device: Metered Dose Inhaler, Device: Connected Inhaler System | Arm Label: Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FP/SAL, Drug: Tiotropium, Drug: Albuterol/salbutamol, Device: DISKUS DPI, Device: RESPIMAT inhaler, Device: Metered Dose Inhaler | Arm Label: Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg; Type: ACTIVE_COMPARATOR; Interventions: Drug: FP/SAL, Drug: Tiotropium, Drug: Albuterol/salbutamol, Device: DISKUS DPI, Device: RESPIMAT inhaler, Device: Metered Dose Inhaler | Intervention Type: DRUG; Name: FF/UMEC/VI; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS | Intervention Type: DRUG; Name: FP/SAL; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DRUG; Name: Albuterol/salbutamol; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS, Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: ELLIPTA DPI; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS | Intervention Type: DEVICE; Name: DISKUS DPI; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: RESPIMAT inhaler; Assigned to Arm(s): Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: Metered Dose Inhaler; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS, Subjects receiving FP/SAL(250/50) mcg + TIO 5 mcg, Subjects receiving FP/SAL(500/50) mcg + TIO 5 mcg | Intervention Type: DEVICE; Name: Connected Inhaler System; Assigned to Arm(s): Subjects receiving FF/UMEC/VI (100/62.5/25) mcg+ CIS, Subjects receiving FF/UMEC/VI (200/62.5/25) mcg+ CIS
B: Arm Label: Arm1: Fluticasone Furoate/ Vilanterol 200/25 mcg; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate/ Vilanterol 200/25 mcg | Arm Label: Arm 2: Fluticasone Furoate/ Vilanterol 100/25 mcg; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate/ Vilanterol 100/25 mcg | Arm Label: Arm 3: Fluticasone Furoate 100 mcg; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate 100 mcg | Intervention Type: DRUG; Name: Fluticasone Furoate/ Vilanterol 200/25 mcg; Assigned to Arm(s): Arm1: Fluticasone Furoate/ Vilanterol 200/25 mcg | Intervention Type: DRUG; Name: Fluticasone Furoate/ Vilanterol 100/25 mcg; Assigned to Arm(s): Arm 2: Fluticasone Furoate/ Vilanterol 100/25 mcg | Intervention Type: DRUG; Name: Fluticasone Furoate 100 mcg; Assigned to Arm(s): Arm 3: Fluticasone Furoate 100 mcg
C: Arm Label: tiotropium 5mcg/day; Type: EXPERIMENTAL; Interventions: Drug: tiotropium 5mcg/day | Arm Label: placebo; Type: EXPERIMENTAL; Interventions: Drug: placebo | Intervention Type: DRUG; Name: tiotropium 5mcg/day; Assigned to Arm(s): tiotropium 5mcg/day | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo
D: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: FOSTER | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Seretide | Intervention Type: DRUG; Name: FOSTER; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Seretide; Assigned to Arm(s): 2

Answer: C