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Make a difference to the health-related quality of life for your patients with COPD 1 2

COPD can make activities such as attending social events with friends or playing with their grandchildren more difficult, impacting quality of life 3
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TRELEGY Ellipta: superior improvement vs. Symbicort Turbuhaler in HRQoL 1
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TRELEGY Ellipta: superior improvement vs. a LAMA/LABA (UMEC/VI) in HRQoL 2

Superior improvement in HRQoL vs. Symbicort Turbuhaler 1

Adapted from Lipson et al. 2017 1
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 Turbuhaler BD (BUD/FOR).1 Co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met

Superior improvement in HRQoL vs. a LAMA/LABA (UMEC/VI) 2

Adapted from Lipson et al. 2018 2
HRQoL determined according to the St. George's Respiratory Questionnaire (SGRQ). Find out more lower down this page. SGRQ MCID=4.0 unit change
Data from the IMPACT trial comparing TRELEGY Ellipta OD to an ICS/LABA (FF/VI) and a LAMA/LABA (UMEC/VI).2 Co-primary endpoints of annual rate of on-treatment moderate/severe exacerbations for TRELEGY Ellipta vs. both comparators were met. Change from baseline in SGRQ score at Week 52 was a secondary endpoint

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:4 5

  • 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 design [1]

    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 Turbuhaler BD (BUD/FOR), with an extension to 52 weeks in a subset of patients. 1

    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
    • Change from baseline CAT score

    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

  • IMPACT trial design [2]

    IMPACT is the first trial to assess, over 52 weeks, the efficacy and safety of the single-inhaler triple therapy TRELEGY Ellipta (FF/UMEC/VI) vs. an ICS/LABA (FF/VI) and vs. a LAMA/LABA (UMEC/VI), in symptomatic patients on COPD maintenance treatments who had experienced at least one exacerbation in the last 12 months. 2

    Primary endpoints:

    • Annual rate of on-treatment moderate/severe exacerbations* for TRELEGY Ellipta vs. both comparators

    Secondary endpoints include:

    • Lung function: change from baseline in trough FEV1 at Week 52
    • Health-related quality of life: change from baseline in SGRQ score at Week 52

    Other endpoints include

    • On-treatment all-cause mortality

    Key inclusion criteria:

    • Patients aged 40 years or older with COPD and a CAT score ≥10 with:
      • FEV1 <50% predicted and ≥1 moderate/severe exacerbation in the previous year, or
      • FEV1 ≥50% to <80% predicted and ≥2 moderate exacerbations or ≥1 severe exacerbation in the previous year
    • Patients were required to be receiving daily maintenance therapy for COPD for at least 3 months prior to screening

    Key exclusion criteria:

    • Current diagnosis of asthma or other respiratory disorders
    • Unresolved pneumonia or COPD exacerbation, or respiratory tract infection ≤14 days or 7 days, respectively
    • Oral/systemic corticosteroid use ≤30 days prior to screening

    *A moderate exacerbation was defined as an exacerbation leading to treatment with antibiotics or systemic glucocorticoids. A severe exacerbation was one resulting in hospitalisation or death

TRELEGY Ellipta quick links

Exacerbation reduction

Lung function improvement

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Footnotes

BD, twice daily; BUD, budesonide; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; LABA, long- acting ß2-agonist; LAMA, long-acting muscarinic antagonist; LS, least squares; MCID, minimal clinically important difference; OD, once daily; 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 ICS and a LABA 6

References

  1. Lipson DA et al. Am J Crit Care Med 2017; 196:438–446
  2. Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
  3. 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 June 2020).
  4. Tabberer M et al. Adv Ther 2018; 35:56–71.
  5. SGUL. SGRQ manual 2009. Available at: http://www.healthstatus.sgul.ac.uk/ SGRQ_download (Accessed June 2020).
  6. Trelegy Local prescribing information based on EMEA V1.

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TRELEGY Ellipta was developed in collaboration with

PM-SA-FVU-WCNT-200011 Date of preparation: September 2020