Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open Label, Randomised, Parallel Group Clinical Study to Evaluate the Effect of the Connected Inhaler System (CIS) on Adherence to Relvar/Breo ELLIPTA Therapy, in Asthmatic Subjects With Poor Control
Brief Summary: GlaxoSmithKline (GSK) in collaboration with Propeller Health has developed a sensor, which can clip on to the ELLIPTA® dry powder inhaler (DPI) and monitor the time and date that the ELLIPTA DPI cover is fully opened and closed. Additionally, a sensor will be attached to the rescue medication metered dose inhaler (MDI). The data from both sensors will be fed back to the subject via an application (app) on smart phone and will be reviewed by the subject's health care professional (HCP) via an online dashboard. The sensors, app, dashboard and systems to provide data comprise the CIS. This study will be the first to evaluate the effect of CIS on adherence to maintenance therapy in subjects with uncontrolled asthma. This is an open-label, randomized, parallel group study in asthmatic subjects currently on a fixed dose inhaled corticosteroid (ICS)/long-acting beta 2 agonist (LABA) maintenance therapy. Eligible subjects will receive RELVAR®/BREO® maintenance therapy via ELLIPTA DPI and salbutamol rescue medication via MDI with sensors attached to both inhalers during the run-in period, which may last for up to 3 months. Eligible subjects will then be randomized into five treatment arms depending on whether the data, from RELVAR/BREO ELLIPTA or RELVAR/BREO ELLIPTA and salbutamol MDI, is fed back to the subject or subject and HCP, or not at all. The treatment period for the study is approximately 6 months and there will be a follow-up period one week post last visit. The total duration of a subject in the study will be approximately 9 months. RELVAR, BREO and ELLIPTA are registered trademarks of GlaxoSmithKline group of companies.


Options:
A: Arm Label: Active Feedback; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Active Feedback | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Active Feedback | Intervention Type: BEHAVIORAL; Name: Active Feedback; Assigned to Arm(s): Active Feedback, Control
B: Arm Label: BreatheSmart System; Type: EXPERIMENTAL; Interventions: Device: BreatheSmart System | Arm Label: Standard of Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Standard of Care | Intervention Type: DEVICE; Name: BreatheSmart System; Assigned to Arm(s): BreatheSmart System | Intervention Type: OTHER; Name: Standard of Care; Assigned to Arm(s): Standard of Care
C: Arm Label: Data on Maintenance use supplied to Subject and HCP; Type: EXPERIMENTAL; Interventions: Drug: RELVAR/BREO, Drug: Salbutamol, Device: Smart phone app, Device: HCP Dashboard, Device: Sensors | Arm Label: Data on Maintenance use supplied to Subject; Type: EXPERIMENTAL; Interventions: Drug: RELVAR/BREO, Drug: Salbutamol, Device: Smart phone app, Device: Sensors | Arm Label: Data on Maintenance and Rescue use supplied to Subject and HCP; Type: EXPERIMENTAL; Interventions: Drug: RELVAR/BREO, Drug: Salbutamol, Device: Smart phone app, Device: HCP Dashboard, Device: Sensors | Arm Label: Data on Maintenance and Rescue use supplied to Subject; Type: EXPERIMENTAL; Interventions: Drug: RELVAR/BREO, Drug: Salbutamol, Device: Smart phone app, Device: Sensors | Arm Label: No data supplied to Subject or HCP; Type: ACTIVE_COMPARATOR; Interventions: Drug: RELVAR/BREO, Drug: Salbutamol, Device: Sensors | Intervention Type: DRUG; Name: RELVAR/BREO; Assigned to Arm(s): Data on Maintenance and Rescue use supplied to Subject, Data on Maintenance and Rescue use supplied to Subject and HCP, Data on Maintenance use supplied to Subject, Data on Maintenance use supplied to Subject and HCP, No data supplied to Subject or HCP | Intervention Type: DRUG; Name: Salbutamol; Assigned to Arm(s): Data on Maintenance and Rescue use supplied to Subject, Data on Maintenance and Rescue use supplied to Subject and HCP, Data on Maintenance use supplied to Subject, Data on Maintenance use supplied to Subject and HCP, No data supplied to Subject or HCP | Intervention Type: DEVICE; Name: Smart phone app; Assigned to Arm(s): Data on Maintenance and Rescue use supplied to Subject, Data on Maintenance and Rescue use supplied to Subject and HCP, Data on Maintenance use supplied to Subject, Data on Maintenance use supplied to Subject and HCP | Intervention Type: DEVICE; Name: HCP Dashboard; Assigned to Arm(s): Data on Maintenance and Rescue use supplied to Subject and HCP, Data on Maintenance use supplied to Subject and HCP | Intervention Type: DEVICE; Name: Sensors; Assigned to Arm(s): Data on Maintenance and Rescue use supplied to Subject, Data on Maintenance and Rescue use supplied to Subject and HCP, Data on Maintenance use supplied to Subject, Data on Maintenance use supplied to Subject and HCP, No data supplied to Subject or HCP
D: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Device: Remote Health Management Sensor Platform | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Remote Health Management Sensor Platform; Assigned to Arm(s): Intervention

Answer: C