Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children Aged 5-11 Years With Asthma on a Background of Inhaled Corticosteroid Therapy
Brief Summary: This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group, placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma. Subjects entering the run-in period will stop their current asthma medication and be given open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and salbutamol/albuterol as required to use throughout the run-in and double-blind treatment period. At Visit 3 subjects meeting the randomization eligibility criteria will receive vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI) once daily for 4 weeks in addition to open-label fluticasone propionate twice daily throughout the treatment period. Primary endpoints consist of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period in all subjects. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at specific time intervals relative to the dose of study drug.


Options:
A: Arm Label: Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate 100mcg, Drug: Vilanterol | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate 100mcg, Drug: Vilanterol | Arm Label: Arm 3; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate 100mcg, Drug: Vilanterol | Arm Label: Arm 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: Fluticasone propionate 100mcg, Drug: Placebo | Intervention Type: DRUG; Name: Fluticasone propionate 100mcg; Assigned to Arm(s): Arm 1, Arm 2, Arm 3, Arm 4 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Arm 4 | Intervention Type: DRUG; Name: Vilanterol; Assigned to Arm(s): Arm 1, Arm 2, Arm 3
B: Arm Label: Fluticasone Furoate (FF); Type: ACTIVE_COMPARATOR; Interventions: Drug: FF | Arm Label: Fluticasone Furoate /Vilanterol (VI); Type: ACTIVE_COMPARATOR; Interventions: Drug: FF/VI | Arm Label: Fluticasone Furoate/GSK573719; Type: EXPERIMENTAL; Interventions: Drug: FF/GSK573719 | Intervention Type: DRUG; Name: FF/GSK573719; Assigned to Arm(s): Fluticasone Furoate/GSK573719 | Intervention Type: DRUG; Name: FF/GSK573719; Assigned to Arm(s): Fluticasone Furoate/GSK573719 | Intervention Type: DRUG; Name: FF/GSK573719; Assigned to Arm(s): Fluticasone Furoate/GSK573719 | Intervention Type: DRUG; Name: FF/GSK573719; Assigned to Arm(s): Fluticasone Furoate/GSK573719 | Intervention Type: DRUG; Name: FF/GSK573719; Assigned to Arm(s): Fluticasone Furoate/GSK573719 | Intervention Type: DRUG; Name: FF; Assigned to Arm(s): Fluticasone Furoate (FF) | Intervention Type: DRUG; Name: FF/VI; Assigned to Arm(s): Fluticasone Furoate /Vilanterol (VI)
C: Arm Label: Fluticasone furoate/GW642444; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate/GW642444 | Arm Label: Fluticasone propionate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate | Intervention Type: DRUG; Name: Fluticasone Furoate/GW642444; Assigned to Arm(s): Fluticasone furoate/GW642444 | Intervention Type: DRUG; Name: Fluticasone propionate; Assigned to Arm(s): Fluticasone propionate
D: Arm Label: arm 1; Type: EXPERIMENTAL; Interventions: Drug: GW685698X | Arm Label: arm 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): arm 2 | Intervention Type: DRUG; Name: GW685698X; Assigned to Arm(s): arm 1

Answer: A