Patient with COPD
The things you do today make a big difference to their tomorrows

Having COPD can make activities such as attending social events with friends or playing with grandchildren more difficult, impacting a patient's quality of life. How could Trelegy Ellipta help?

  • Trelegy Ellipta delivered superior HRQoL improvement vs. an ICS/LABA at week 243

    COPD Assessment Test (CAT) Scores (other end point)

    Graph comparing trelegy ellipta to ICS LABA COPD maintenance therapy

    Adapted from Tabberer M et al. 20183
    CAT MCID: ≥2 reduction from baseline CAT score3
    MCID: Minimal clinically important difference

  • Trelegy Ellipta: Superior Improvement in HRQoL vs. an ICS/LABA2

    St George's Respiratory Questionnaire (SGRQ) (Co Primary endpoint)

    NA

    Adapted from Lipson et al 20172
    SGRQ MCID: 4 unit change
    MCID: Minimal clinically important difference

What is the COPD Assessment Test (CAT)?4

The CAT is a short, simple, patient-completed questionnaire assessing the effects of COPD on a patient’s health.

The CAT asks patients how affected they are by COPD across 8 different measures: cough, phlegm, chest tightness, breathlessness, effect on daily activities, confidence in leaving home, sleep and energy levels.

CAT is designed to provide a reliable measure of overall COPD severity from the patient’s perspective, independent of language.

Patients rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40.

Higher scores indicate greater disease impact

What is the St George's Respiratory Questionnaire (SGRQ) test?3

SGRQ is comprised of 3 main domains:

Symptoms: the effect of respiratory symptoms and their frequency and severity.

Activities: activities that cause, or are limited by breathlessness

Impacts: aspects concerned with social functioning and psychological disturbances resulting from airway disease.

40 items across the 3 domains giving a scoring range of 0–100.

Higher scores indicate greater disease impact

See more Trelegy Ellipta clinical data

Key trial design

  • FULFIL was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study designed to assess the efficacy and safety of the single-inhaler triple therapy Trelegy Ellipta OD (FF/UMEC/VI) vs. Symbicort Turbohaler BD (BUD/FOR), with an extension to 52 weeks in a subset of patients.2

    FULFIL study design

    Co-primary endpoints:

    • Change from baseline in trough FEV1 and SGRQ score at Week 24

    Secondary endpoints include:

    • Annual rate of moderate/severe COPD exacerbations

    Key inclusion criteria

    • Patients with COPD with a FEV1 <50% and a CAT score ≥10, or
    • Patients with a FEV1 ≥50% to <80% and a CAT score ≥10, and either ≥2 moderate exacerbations in the past year or ≥1 severe exacerbation in the past year*
    • Aged ≥40 years

    Key exclusion criteria:

    • Current diagnosis of asthma causing patient symptoms
    • Unresolved pneumonia or severe COPD exacerbation

    *A moderate exacerbation was defined as having worsening symptoms of COPD that required treatment with oral/ systemic corticosteroids and/or antibiotics. A severe exacerbation was defined as worsening symptoms of COPD that required treatment with inpatient hospitalisation

Prescribing Information Links

Trelegy Ellipta Prescribing Information (pdf)

Trelegy Ellipta OD is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist.1

Footnotes

BD, twice daily; BUD/FOR, budesonide/formoterol; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; FF/UMEC/VI, fluticasone furoate/umeclidinium/vilanterol; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; HRQoL, health related quality of life; SGRQ, St George’s Respiratory Questionnaire;

References

  1. TRELEGY Ellipta SmPC
  2. Lipson DA et al. Am J Crit Care Med 2017; 196:438–446.
  3. Tabberer M et al. Adv Ther 2018; 35:56–71.
  4. Jones PW et al. Eur Respir J 2009; 34;648-654.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441.

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Trademarks are the property of their respective owners
Trelegy Ellipta was developed in collaboration with

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November 2021 | PM-GB-FVU-WCNT-200016 (V4.0)