Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-blind, Double-dummy, Parallel Group, Multicenter Study of Once Daily Fluticasone Furoate/Vilanterol 100/25 mcg Inhalation Powder, Twice Daily Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Twice Daily Fluticasone Propionate 250 mcg Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents Already Adequately Controlled on Twice-daily Inhaled Corticosteroid and Long-acting beta2 Agonist
Brief Summary: This study is a randomized, double-blind, double-dummy, parallel group, multicenter, non-inferiority study. The study will enroll adult and adolescent asthmatic subjects who are currently receiving mid dose inhaled corticosteroids (ICS) plus long-acting beta2-agonist (LABA) (equivalent to fluticasone propionate \[FP\]/salmeterol 250/50 microgram \[mcg\]twice daily \[BD\]), either via a fixed dose combination product or through separate inhalers. The study consists of a LABA washout period of 5 days and a run-in period of 4 weeks, followed by a treatment period of 24 weeks, and a follow up contact period of one week. The total duration of the study is 30 weeks. Approximately 1461 subjects will be randomized to one of the following three treatments (487 per treatment): fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg once daily (OD) in the evening (PM) via ELLIPTA™ inhaler plus placebo BD via ACCUHALER™/DISKUS™; FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler; FP 250 mcg BD via ACCUHALER/DISKUS inhaler plus placebo OD (PM) via ELLIPTA inhaler. In addition, all subjects will be supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms. This study will determine if FF/VI 100/25 mcg OD via ELLIPTA inhaler is non-inferior to FP/salmeterol 250/50 mcg BD via ACCUHALER/DISKUS inhaler in adult and adolescent asthmatic subjects already adequately controlled on a twice-daily ICS/LABA.

SERETIDE, ELLIPTA, ACCUHALER, RELVAR, and DISKUS are trademarks of the GlaxoSmithKline Group of Companies.


Options:
A: Arm Label: Symbicort; Type: ACTIVE_COMPARATOR; Interventions: Drug: Budesonide/formoterol (SYMBICORT) pMDI | Arm Label: Budesonide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Budesonide HFA pMDI | Intervention Type: DRUG; Name: Budesonide/formoterol (SYMBICORT) pMDI; Assigned to Arm(s): Symbicort | Intervention Type: DRUG; Name: Budesonide HFA pMDI; Assigned to Arm(s): Budesonide
B: Arm Label: Fluticasone Furoate OD and Placebo BID; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone furoate, Drug: Placebo | Arm Label: Fluticasone Propionate BID and Placebo OD; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate, Drug: Placebo | Arm Label: Placebo only BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Fluticasone propionate; Assigned to Arm(s): Fluticasone Propionate BID and Placebo OD | Intervention Type: DRUG; Name: Fluticasone furoate; Assigned to Arm(s): Fluticasone Furoate OD and Placebo BID | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Fluticasone Furoate OD and Placebo BID, Fluticasone Propionate BID and Placebo OD, Placebo only BID
C: Arm Label: Vilanterol; Type: EXPERIMENTAL; Interventions: Drug: Vilanterol, Drug: Placebo Inhalation Powder Diskus | Arm Label: Salmeterol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Salmeterol Inhalation Powder, Drug: Placebo Inhalation Powder NDPI | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Inhalation Powder NDPI, Drug: Placebo Inhalation Powder Diskus | Intervention Type: DRUG; Name: Vilanterol; Assigned to Arm(s): Vilanterol | Intervention Type: DRUG; Name: Salmeterol Inhalation Powder; Assigned to Arm(s): Salmeterol | Intervention Type: DRUG; Name: Placebo Inhalation Powder NDPI; Assigned to Arm(s): Placebo, Salmeterol | Intervention Type: DRUG; Name: Placebo Inhalation Powder Diskus; Assigned to Arm(s): Placebo, Vilanterol
D: Arm Label: Fluticasone Furoate/Vilanterol 100/25 mcg; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler, Drug: Placebo inhalation powder via ACCUHALER/DISKUS inhaler | Arm Label: Fluticasone Propionate/Salmeterol 250/50 mcg; Type: EXPERIMENTAL; Interventions: Drug: Placebo inhalation powders via ELLIPTA inhaler, Drug: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler | Arm Label: Fluticasone Propionate 250 mcg; Type: EXPERIMENTAL; Interventions: Drug: Placebo inhalation powders via ELLIPTA inhaler, Drug: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler | Intervention Type: DRUG; Name: Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler; Assigned to Arm(s): Fluticasone Furoate/Vilanterol 100/25 mcg | Intervention Type: DRUG; Name: Placebo inhalation powders via ELLIPTA inhaler; Assigned to Arm(s): Fluticasone Propionate 250 mcg, Fluticasone Propionate/Salmeterol 250/50 mcg | Intervention Type: DRUG; Name: Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler; Assigned to Arm(s): Fluticasone Propionate/Salmeterol 250/50 mcg | Intervention Type: DRUG; Name: Placebo inhalation powder via ACCUHALER/DISKUS inhaler; Assigned to Arm(s): Fluticasone Furoate/Vilanterol 100/25 mcg | Intervention Type: DRUG; Name: Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler; Assigned to Arm(s): Fluticasone Propionate 250 mcg

Answer: D