Patient with COPD
Trelegy Ellipta and health-related quality of life (HRQoL)

Help your patients focus on a life beyond COPD

COPD can make activities such as attending social events with friends or playing with grandchildren more difficult, impacting a patient's quality of life¹. How could Trelegy Ellipta help?

Trelegy Ellipta delivered superior improvement in HRQoL vs. an ICS/LABA²

Graph comparing trelegy ellipta to ICS LABA COPD maintenance therapy

Adapted from Lipson et al. 2017²
HRQoL determined according to the St. George's Respiratory Questionnaire (SGRQ). Find out more lower down this page.
SGRQ MCID=4.0 unit change
The figures have been rounded from -6.57 and -4.33, respectively
Data from the FULFIL study comparing Trelegy Ellipta OD to Symbicort Turbohaler BD (BUD/FOR).² Co-primary endpoints of change from baseline in trough FEV₁ and SGRQ score at Week 24 were both met

What is the St. George’s Respiratory Questionnaire?

Health-related quality of life (HRQoL) is often measured using the patient-administered St. George’s Respiratory Questionnaire, which is comprised of 3 main domains:³ ⁴

  • Symptoms: the effect of respiratory symptoms and their frequency and severity
  • Activity: activities that cause, or are limited by, breathlessness
  • Impacts: aspects concerned with social functioning and psychological disturbances resulting from airway disease

Key trial design

  • FULFIL study design²

    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

Footnotes

BD, twice daily; BUD, budesonide; CAT, COPD assessment test; FEV₁, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting ß₂-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; QoL, quality of life; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol

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.⁵

Trelegy Ellipta is generally well tolerated. Common adverse reactions include: headache, nasopharyngitis, influenza, upper respiratory tract infection, pneumonia, back pain, rhinitis, cough, pharyngitis, arthralgia, sinusitis, oropharyngeal pain, bronchitis, constipation, candidiasis of mouth and throat, urinary tract infection. This is not an exhaustive list. Please consult the Summary of Product Characteristics for a full list of adverse reactions before prescribing.⁵

In common with other corticosteroid-containing medicines, there is an increased risk of pneumonia in patients with COPD treated with Trelegy Ellipta.⁵

References

  1. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD). 2020. Available at: https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.1wms.pdf (Accessed May 2020).
  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. SGUL. SGRQ manual 2009. Available at: http://www.healthstatus.sgul.ac.uk/ SGRQ_download (Accessed May 2020).
  5. TRELEGY Ellipta SmPC.

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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Trelegy Ellipta was developed in collaboration with

PM-GB-FVU-WCNT-200016 | October 2020