Pulmonary Disease, Chronic ObstructivePhase 4LEGENDNCT03949842

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

A Phase 4 study testing Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists and Fluticasone furoate/umeclidinium/vilanterol in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists and Fluticasone furoate/umeclidinium/vilanterol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 3 sitesUnited States
Study dates: 27 Jun 2019to 30 Nov 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

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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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Waterbury, Connecticut, 06708

Other trials in United States

About this study

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

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
Being tested: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists, Fluticasone furoate/umeclidinium/vilanterol
Keywords: Fluticasone furoate, Umeclidinium bromide, Vilanterol, COPD, ELLIPTA, TRELEGY, MITT, SITT
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonistsDrug
A fixed dose of combination ICS/LABA plus LAMA once-daily was administered to COPD subjects using two separate non-ELLIPTA devices.
Fluticasone furoate/umeclidinium/vilanterolDrug
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.

Study groups in NCT03949842
Study group	Role	What they receive
Subjects who inhaled non-ELLIPTA MITT	Experimental	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. Receives: Drug: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists
Subjects receiving TRELEGY ELLIPTA SITT	Experimental	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. Receives: Drug: Fluticasone furoate/umeclidinium/vilanterol

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized rate of moderate, severe COPD exacerbations
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.
Measured: 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 201930 Nov 2022

First posted14 May 2019
Study start27 Jun 2019
Primary completion30 Nov 2022 (estimated)
Study completion30 Nov 2022 (estimated)

Why it stopped: The decision to end the study was based on a change in GSK strategy. No subjects were enrolled into the study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
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)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03949842
Sponsor's protocol ID: 206860
Acronym: LEGEND
Status last verified: Apr 2020
First submitted: 13 May 2019
Last updated: 22 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03949842
Acronym / sponsor ID: LEGEND / 206860
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Fluticasone furoate, Umeclidinium bromide, Vilanterol, COPD, ELLIPTA, TRELEGY, MITT, SITT
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The decision to end the study was based on a change in GSK strategy. No subjects were enrolled into the study.
Enrolment: 0 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 27 Jun 2019 (actual)
Primary completion: 30 Nov 2022 (estimated)
Study completion: 30 Nov 2022 (estimated)
First posted: 14 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Subjects who inhaled non-ELLIPTA MITT	Experimental	Drug: Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonistsSubjects 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	Experimental	Drug: Fluticasone furoate/umeclidinium/vilanterolSubjects 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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).

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonistsA fixed dose of combination ICS/LABA plus LAMA once-daily was administered to COPD subjects using two separate non-ELLIPTA devices.	Drug	Subjects who inhaled non-ELLIPTA MITT
Fluticasone furoate/umeclidinium/vilanterolThe 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.	Drug	Subjects receiving TRELEGY ELLIPTA SITT

Primary outcome

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.

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
Individual participant dataSharing planned: No

Related trials for Pulmonary Disease, Chronic Obstructive

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized rate of moderate, severe COPD exacerbations (time frame: 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03949842.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.