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

NCT03949842 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-04-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-27
Primary Completion
2022-11-30
Completion
2022-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03949842 on ClinicalTrials.gov