Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study
Status:
Withdrawn
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to assess the effectiveness of TRELEGY ELLIPTA single
inhaler triple therapy (SITT) (fluticasone furoate/umeclidinium bromide/vilanterol
[FF/UMEC/VI]) relative to non-ELLIPTA multiple inhaler triple therapies (MITT) of inhaled
corticosteroids/long-acting beta2-adrenergic receptor agonists/muscarinic receptor
antagonists (ICS/LABA/LAMA) within a routine clinical practice setting. This is a
non-randomized, interventional and self-controlled cohort study conducted to collect data in
routine practice. This study will have two periods where in retrospective data will be
collected in pre-switch period and prospective data will be collected in post-switch periods.
Subjects will be switched from non-ELLIPTA MITT to TRELEGY ELLIPTA. The pre-switch period is
of 52 weeks and post-switch period will be of 52 weeks. Additionally subjects will receive
safety follow-up call at 26 weeks and 52 weeks for safety monitoring. Approximately 1300
subjects will be enrolled for this study. TRELEGY ELLIPTA is a registered trademark of the
GlaxoSmithKline (GSK) group of companies.