NCT03949842

Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study

A Comparison of the Clinical Effectiveness of Inhaled Triple Therapy (Fluticasone Furoate / Umeclidinium Bromide / Vilanterol) in a Single Inhaler (TRELEGY™ ELLIPTA™) With Inhaled Non-ELLIPTA™ Multiple Inhaler Triple Therapies in COPD Patients in the US Within a Usual Care Setting in a Prospective Pre-Post Study

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists	A fixed dose of combination ICS/LABA plus LAMA once-daily was administered to COPD subjects using two separate non-ELLIPTA devices.
DRUG	Fluticasone furoate/umeclidinium/vilanterol	The first strip will contain FF at a dose strength of 100 mcg will be blended with lactose. The second strip will be contain UMEC and VI at a dose strength of 25 mcg and 62.5 mcg blended with lactose and magnesium stearate with respectively.

Timeline

• Start date: 2019-06-27
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2019-05-14
• Last updated: 2020-04-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study