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

Phase 4

Withdrawn

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists; Drug: Fluticasone furoate/umeclidinium/vilanterol

• Registration Number: NCT03949842
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2019-06-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-21
• Last Update Posted: 2020-04-22
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Subjects who inhaled non-ELLIPTA MITT	Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists	Subjects with moderate or severe exacerbation in the past year and history of use of inhaled non-ELLIPTA MITT of ICS/LABA/LAMA within a routine clinical practice setting in the 52-week retrospective pre-switch period.
Subjects receiving TRELEGY ELLIPTA SITT	Fluticasone furoate/umeclidinium/vilanterol	Subjects will receive FF/UMEC/VI (100 microgram \[mcg\]/62.5 mcg/25 mcg), inhalation powder, once daily, in a single device (TRELEGY ELLIPTA) in the 52-week prospective post-switch period.

Primary Outcome Measures

Name	Time	Method
Annualized rate of moderate, severe COPD exacerbations	104 weeks	Moderate and severe COPD exacerbations will be defined using an algorithm agreed upon by GlaxoSmithKline and the health plans that identifies these events from health plan medical claims data. Moderate exacerbation is any physician office visit, urgent care visit or emergency room visit for COPD where any oral corticosteroids or antibiotics are prescribed during visit. Severe exacerbations are any COPD related inpatient visit. Exacerbations will be determined in the same fashion in the retrospective pre-switch period and the prospective post switch period.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Layton, Utah, United States