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Trelegy Ellipta and Lung Function Improvement

Help improve lung function for COPD patients with a once-daily single-inhaler Triple Therapy 2,7

Breathing Better: How single-inhaler Triple Therapy could help your patients with COPD from today

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Over 50% of patients treated with COPD maintenance therapies, including ICS/LABA, continue to suffer from breathlessness4
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TRELEGY Ellipta provides statistically superior lung function improvement vs.budesonide/formoterol2
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TRELEGY Ellipta provides statistically superior lung function improvement vs.a LAMA/LABA (UMEC/VI)3

Statistically superior improvement in lung function vs. budesonide/formoterol2

Graph showing lung function improvement

Adapted from Lipson et al. 20172
Data from the FULFIL study comparing TRELEGY Ellipta OD to BUD/FOR.2 Co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met. Further information on the FULFIL study lower down this page
*MCID: Minimal Clinically Important Difference. Patients with COPD have been shown to perceive an improvement of ≥100 mL in trough FEV1 as beneficial5

Statistically superior improvement in lung function vs. a LAMA/LABA (UMEC/VI)3,6

Graph showing lung function improvement

Adapted from Lipson et al. 20183,6
Data from the IMPACT Trial comparing TRELEGY Ellipta OD to an ICS/LABA (FF/VI) and a LAMA/LABA (UMEC/VI).3,6 Primary endpoints of annual rate of on-treatment moderate/severe exacerbations for TRELEGY Ellipta vs. both comparators were met. Change from baseline in trough FEV1 at Week 52 was a secondary endpoint

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. budesonide/formoterol with an extension to 52 weeks in a subset of patients.2

    FULFIL study design²

    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 design³

    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.3

    IMPACT trial design³

    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; CI, confidence interval; FEV1, forced expiratory volume in one second; FF, fluticasone furoate; FOR, formoterol; ICS, inhaled corticosteroid; LABA, long-acting ß2-agonist; LAMA, long-acting muscarinic antagonist; LS, least squares; OD, once daily; MCID, minimal clinically important difference; 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, or a combination of a LAMA and a LABA¹

References

  1. TRELEGY Ellipta SmPC. Available at https://www.medicines.ie. Accessed April 2024.
  2. Lipson DA et al. Am J Crit Care Med 2017; 196:438–446.
  3. Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
  4. Rebordosa C et al. Pharmacoepidemiol Drug Saf 2019; 28:126–133, including supplementary material.
  5. Jones PW et al. Am J Respir Crit Care Med 2014; 189:250–255.
  6. GSK, Data on File. RF/TLY/0067/18. IMPACT Study: trough FEV1 data over 52 weeks.
  7. Tabberer M et al. Adv Ther 2018; 35:56–71.

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-240002