The Clinical Effectiveness of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in a Single Inhaler (TRELEGY™ ELLIPTA™) When Compared With Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients Within a Usual Care Setting

The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA relative
to non-ELLIPTA Multiple Inhaler Triple Therapies (MITT) for Chronic Obstructive Pulmonary
Disease (COPD) control within the usual clinical practice setting. The study will be
conducted once TRELEGY ELLIPTA has been approved in the countries in which the study will be
conducted and is available commercially. This is a randomized, open-label, effectiveness,
phase 4 study of 24 weeks' duration in COPD subjects to evaluate TRELEGY ELLIPTA (fluticasone
furoate [FF]/vilanterol [VI]/umeclidinium bromide [UMEC]: 100 microgram [mcg]/62.5 mcg/25
mcg) inhalation powder taken once daily using a single ELLIPTA inhaler compared with any
non-ELLIPTA MITT in the usual care setting. Effectiveness of TRELEGY ELLIPTA will be assessed
by comparing proportion of COPD Assessment Test (CAT) responders at Week 24 between two
treatment groups. TRELEGY and ELLIPTA are trademarks of GlaxoSmithKline (GSK) group of
companies. The study will enroll approximately 3000 subjects.