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

Single-inhaler Triple Therapy could help your COPD patients breathe better from today1,2

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COPD can make activities such as attending social events with friends or playing with their grandchildren more difficult, impacting quality of life3
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TRELEGY Ellipta: Statistically superior improvement vs. budesonide/formoterol in HRQoL1
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TRELEGY Ellipta: Statistically superior improvement vs. a LAMA/LABA (UMEC/VI) in HRQoL2

Statistically superior improvement in HRQoL vs. budesonide/formoterol1

Graph showing statistically superior improvement in HRQoL vs. budesonide/formoterol

Adapted from Lipson et al. 20171
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 BUD/FOR.1 Co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met

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

Graph showing statistically superior improvement in HRQoL vs. a LAMA/LABA

Adapted from Lipson et al. 20182
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

Key trial design

  • FULFIL study design¹

    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. budesonide/formoterol with an extension to 52 weeks in a subset of patients.1

    FULFILL study

    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 design²

    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

    IMPACT Trial

    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

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; 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, or a combination of a LAMA and a LABA4

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). 2024.
  4. TRELEGY Ellipta SmPC. Available at www.medicines.ie. Accessed April 2024.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Trelegy is a registered trademark of the GlaxoSmithKline group of companies.

TRELEGY Ellipta was developed in collaboration with

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Last Updated: April 2024 PM-IE-FVU-WCNT-240003