Dataset from 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

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.