Dataset from A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powder Inhaler in Subjects With Inadequately Controlled Asthma

A once-daily 'closed' triple FDC therapy of FF/UMEC/VI via a single ELLIPTA® dry powder
inhaler (DPI) is being developed by GlaxoSmithKline (GSK) with the aim of providing a new
treatment option for the management of asthma by improving lung function, health-related
quality of life (HRQoL) and symptom control over established combination therapies. This is a
phase III, multi-center, active-controlled, double-blind, parallel-group study to compare the
efficacy, safety and tolerability of the FDC of FF/UMEC/VI with the FDC of FF/VI. This study
has 5 phases: Pre-Screening (Visit 0), Screening/Run-in, Enrolment/Stabilization,
Randomization/Treatment, and Follow up. At Visit 1 (Screening), subjects meeting all protocol
defined inclusion/exclusion criteria will enter a 3-week run-in period and will receive fixed
dose inhaled corticosteroid/long-acting beta agonist (ICS/LABA) (fluticasone/salmeterol,
250/50 micrograms (mcg), via the DISKUS® DPI) one inhalation twice a day. At Visit 2
(Enrolment), eligible subjects will be enrolled into the 2-week stabilization period to
receive FF/VI (100/25 mcg via the ELLIPTA DPI once a day, in the morning). At the conclusion
of the stabilization period (Visit 3), all subjects who meet the pre-defined randomization
criteria will be randomized 1:1:1:1:1:1 during the treatment period to receive either
FF/UMEC/VI (100/62.5/25 mcg; 200/62.5/25 mcg; 100/31.25/25 mcg; 200/31.25/25 mcg) or FF/VI
(100/25 mcg; 200/25 mcg) via the ELLIPTA DPI once daily in the morning. The duration of the
treatment period is variable but will be a minimum of 24 weeks and a maximum of 52 weeks.
Subjects will have up to 6 on-treatment clinic visits scheduled at Visits 3, 4, 5, 6, 7 and
8/End of Study (EOS) (Weeks 0, 4, 12, 24, 36 and 52, respectively). A follow-up visit will be
conducted approximately 7 days after the end of treatment period or, if applicable, after the
early withdrawal visit. Subjects will be provided with short acting albuterol/salbutamol to
be used on an as-needed basis (rescue medication) throughout the study. Approximately 2250
subjects will be randomized, with approximately 375 subjects randomized to each of the 6
double-blind treatment arms to ensure approximately 337 evaluable subjects per treatment arm.
DISKUS and ELLIPTA are registered trademarks of GSK groups of companies.