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

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ClinicalTrials.gov Identifier: NCT03949842
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists Drug: Fluticasone furoate/umeclidinium/vilanterol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a retrospective pre-switch and prospective post-switch study design. Subjects will be on their usual care for the retrospective pre-switch period of the study, then they are enrolled into the study and switched onto Trelegy or FF/UMEC/VI for the prospective period.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Arm Intervention/treatment
Experimental: Subjects who inhaled non-ELLIPTA MITT
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.
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.

Experimental: Subjects receiving TRELEGY ELLIPTA SITT
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.
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.




Primary Outcome Measures :
  1. Annualized rate of moderate, severe COPD exacerbations [ Time Frame: 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Subject must be at least 40 years of age at the time of signing the informed consent.
  • Subjects with a documented physician diagnosis of COPD.
  • Subjects who have been prescribed non-ELLIPTA MITT for daily use for at least 52 weeks prior to Visit 1.
  • Male and/or female. Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).

Exclusion Criteria

  • Women who are: Pregnant or lactating or are planning on becoming pregnant during the study and of child bearing potential.
  • Subjects with an exacerbation with an onset within 4 weeks before Visit 1 must not be enrolled. Enrollment should be delayed until at least 4 weeks after the onset of an exacerbation or until the exacerbation has resolved, whichever is the longer.
  • Subjects with any life threatening condition (low probability in the opinion of the Investigator of 52 weeks survival due to severity of COPD or co-morbid condition at Visit 1.
  • Subjects with historical or current evidence of uncontrolled or clinically significant disease. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the effectiveness or safety analysis if the disease/condition exacerbated during the study.
  • Subjects with severe milk-protein allergy or who have demonstrated hypersensitivity to FF/UMEC/VI or any of the excipients in TRELEGY ELLIPTA.
  • Subjects currently participating in any other study.
  • Subjects taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t1/2) of completion of the prior investigational study (whichever is the longer of the two).
  • Subjects who are planning or may plan to change health plan or physician/investigator during the 52-week study.
  • Subjects who, in the opinion of the treating physician, are considered to be a chronic user of oral corticosteroids (including oral and injectable) for respiratory or other indication in the past 52 weeks (if unsure discuss with the medical monitor prior to screening).
  • Subjects who have received a course of systemic corticosteroids for reasons other than COPD exacerbations within the 4 weeks prior to Visit 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949842


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations
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United States, Connecticut
GSK Investigational Site Recruiting
Waterbury, Connecticut, United States, 06708
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: David G. Hill         
United States, North Carolina
GSK Investigational Site Recruiting
Charlotte, North Carolina, United States, 28207
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Selwyn Spangenthal         
GSK Investigational Site Recruiting
Mooresville, North Carolina, United States, 28117
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Sever C. Surdulescu         
United States, Oregon
GSK Investigational Site Recruiting
Portland, Oregon, United States, 97220
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Melvin Morganroth         
United States, South Carolina
GSK Investigational Site Recruiting
Lancaster, South Carolina, United States, 29720
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Keith Shealy         
GSK Investigational Site Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: James J Carswell         
GSK Investigational Site Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Arun Adlakha         
United States, Texas
GSK Investigational Site Recruiting
Conroe, Texas, United States, 77304
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Centre    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Principal Investigator: Ashesh Desai         
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03949842     History of Changes
Other Study ID Numbers: 206860
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by GlaxoSmithKline:
Fluticasone furoate
Umeclidinium bromide
Vilanterol
COPD
ELLIPTA
TRELEGY
MITT
SITT

Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Fluticasone
Bromides
Adrenergic Agents
Muscarinic Antagonists
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anticonvulsants
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents