Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol)

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Trelegy demonstrated superior lung function improvement vs. other COPD single-inhaler triple therapies in a network meta-analysis of 23 randomised controlled trials1

Network meta-analysis of 23 RCTs of adult COPD patients eligible for triple therapy, 5 of which reported FEV1 endpoints at 24 weeks & 15 at 12 weeks. Based on a Frequentist Fixed Effect (FE) model. This methodology is aligned with the Cochrane principles.1

  • New data - Single Inhaler Triple Therapies compared in a NMA

    Watch the short video below to hear from Professor David Halpin who will provide an overview of:

    • What a network meta-analysis is and how they sit in the heirarchy of evidence (no head-to-head randomised clinical trials exist for single inhaler triple therapies)
    • How this particular network meta-analysis was structured and it’s limitations
    • An overview of the key conclusions from this network meta-analysis

    LAMA/LABAs are indicated as maintenance bronchodilator treatments to relieve symptoms in adult patients with COPD.

    Other NMAs exist which differ in their methodology and study inclusion which do not show any statistical differences between SITTs. No head-to-head randomised control clinical trials exist for single inhaler triple therapies.

    Difference in improvement in lung function for Trelegy vs. other COPD single inhaler triple therapies

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    Network meta-analysis of 23 RCTs of adult COPD patients eligible for triple therapy, 5 of which reported FEV1 endpoints at 24 weeks & 15 at 12 weeks. Analysis based on a Frequentist Fixed Effect (FE) model. This methodology is aligned with Cochrane principles.

  • Trelegy Ellipta delivered superior improvement in lung function vs an ICS/LABA2

    Lung function improvement graph

    Adapted from Lipson et al. 20172
    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. Further information on the FULFIL study further down this page.
    *MCID: Minimal Clinically Important Difference. Patients with COPD have been shown to perceive an improvement of ≥100mL in trough FEV1 as beneficial.
    Doses shown as delivered doses, equating to a pre-dispensed dose of: FF/UMEC/VI 100/62.5/25 and BUD/FOR 400/12

    READ FULFIL STUDY

LUNG FUNCTION IMPACT IN A REAL WORLD SETTING

See more Trelegy Ellipta clinical data

Exacerbation rate reduction

Health-related quality of life improvement

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

IMPACT trial in COPD

Video - IMPACT Trial Explained

Determining the patient benefit that could be achieved by adding an inhaled corticosteroid to dual bronchodilator therapy.

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Which patients can benefit from Trelegy Ellipta?

See the indication, patient profile, plus guidance on spotting patients at risk of an exacerbation.

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Three molecules next to each other

Mechanism of action

Learn about the design of the three molecules in Trelegy Ellipta: fluticasone furoate, umeclidinium, and vilanterol.

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Prescribing Information Links

Trelegy Ellipta Prescribing Information

Seretide Accuhaler 50/500 (salmeterol/fluticasone propionate) Prescribing Information

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.3

Seretide (50 micrograms salmeterol and 500 micrograms fluticasone propionate) is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Footnotes

BD, twice daily; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; SGRQ, St George’s Respiratory Questionnaire

References

  1. Ismaila AS;Adv Ther;2022;1-22
  2. Lipson DA et al. Am J Crit Care Med 2017; 196:438-446.
  3. 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.

March 2023 | PM-GB-FVU-WCNT-200015 (V6.0)