Dataset from A Phase IV, 12 Week, Randomised, Double-blind, Double-dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), With Tiotropium Monotherapy Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

COPD is a progressive disease characterized by increasing obstruction to airflow and the
progressive development of respiratory symptoms including chronic cough, increased sputum
production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/
Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is
combination of FF/UMEC/VI in a single device is being developed with the aim of providing a
new treatment option for the management of advanced COPD. The primary purpose of this study
is to evaluate lung function and health related quality of life (HRQoL) after 84 days of
treatment with a single inhaler triple therapy combination of FF/ UMEC/VI once daily via the
ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in
subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in
the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy
throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the
study. The total study duration will be approximately 17 weeks including, 4-week run-in
period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered
trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered
trademarks of Boeringher Ingelheim.