Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomised Open-label Study to Compare the Effectiveness of the Fixed Dose Combination of FF/UMEC/VI (Using the Connected Inhaler System) With the Combination of FP/SAL Plus Tiotropium (Without the Connected Inhaler System) in Participants With Inadequately Controlled Asthma
Brief Summary: Asthma is a common, chronic respiratory disease affecting 1-18 percent of the population. It is accepted that much of the uncontrolled asthma is due to poor adherence and asthma outcomes in such cases may improve simply by increasing adherence to available treatments. GlaxoSmithKline (GSK) has developed a sensor, which clips on to the ELLIPTA® dry powder inhaler (DPI). This will inform subjects if/when they have taken their medication that is in the ELLIPTA inhaler, as well as other information, including: asthma management strategies, tracking of symptoms, asthma triggers, medication reminders and daily asthma forecasts. The sensors, application (app), and provider portal that provide data are subsequently described as the CIS. The combination of once-daily FF/UMEC/VI with the CIS will improve the disease management and adherence. Thus, this study is designed to study the effectiveness and adherence of single inhaler triple therapy (SITT) of FF/UMEC/VI with the CIS as compared to multiple inhaler triple therapy (MITT) of the combination of FP/SAL plus TIO without CIS in subjects with inadequately controlled asthma. The study randomization will be stratified by pre-study inhaled corticosteroids (ICS) dosage strength (mid- or high-dose). Subjects will be randomized in a 1:1 ratio to receive either FF/UMEC/VI delivered via the ELLIPTA DPI with the CIS or FP/SAL delivered via the DISKUS® DPI (with sensor only) plus TIO delivered via the RESPIMAT inhaler (without sensor). The maximum study duration will be approximately 29 weeks, which comprised of prescreen/ screening/ randomization period of up to 4 weeks, 24-week treatment period and a 1-week follow-up period. Approximately 1006 subjects will be randomized in the study. ELLIPTA and DISKUS are registered trademarks of GlaxoSmithKline (GSK) group of companies.


Options:
A: Arm Label: MF/F MDI 200/10 mcg BID; Type: EXPERIMENTAL; Interventions: Drug: Mometasone furoate/formoterol (MF/F) MDI | Arm Label: F/SC DPI 250/50 mcg BID; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate/salmeterol (F/SC) DPI | Intervention Type: DRUG; Name: Mometasone furoate/formoterol (MF/F) MDI; Assigned to Arm(s): MF/F MDI 200/10 mcg BID | Intervention Type: DRUG; Name: Fluticasone propionate/salmeterol (F/SC) DPI; Assigned to Arm(s): F/SC DPI 250/50 mcg BID
B: Arm Label: Fluticasone Furoate/Vilanterol; Type: EXPERIMENTAL; Interventions: Drug: Fluticasone Furoate, Drug: Vilanterol | Arm Label: FP/S OR BUD/F; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fluticasone propionate, Drug: Salmeterol, Drug: Budesonide, Drug: Formoterol Fumarate | Intervention Type: DRUG; Name: Fluticasone Furoate; Assigned to Arm(s): Fluticasone Furoate/Vilanterol | Intervention Type: DRUG; Name: Vilanterol; Assigned to Arm(s): Fluticasone Furoate/Vilanterol | Intervention Type: DRUG; Name: Fluticasone propionate; Assigned to Arm(s): FP/S OR BUD/F | Intervention Type: DRUG; Name: Salmeterol; Assigned to Arm(s): FP/S OR BUD/F | Intervention Type: DRUG; Name: Budesonide; Assigned to Arm(s): FP/S OR BUD/F | Intervention Type: DRUG; Name: Formoterol Fumarate; Assigned to Arm(s): FP/S OR BUD/F
C: 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
D: Arm Label: Arm 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Drug: GW685698X | Intervention Type: DRUG; Name: GW685698X; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Arm 1

Answer: C