You are now leaving GSK’s website

This link will take you to a non-GSK website. GSK does not recommend, endorse or accept liability for sites controlled by third-parties.

Continue

Go back

For your patients with COPD who are not adequately treated despite ICS/LABA or LAMA/LABA maintenance therapy, TRELEGY Ellipta could make a difference to their breathlessness.1 2

Explore the evidence to see why.

  • In the landmark IMPACT trial, TRELEGY Ellipta demonstrated statistically superior improvements in trough FEV1 vs. FF/VI at 52 weeks1 2

    Reproduced from GSK Data-on-File.2

    The annual rate of on-treatment moderate/severe COPD exacerbations (primary endpoint) was significantly reduced with TRELEGY Ellipta vs. FF/VI and UMEC/VI (p<0.001 for both comparators).1

  • In the FULFIL study, TRELEGY Ellipta offered a statistically superior improvement in trough FEV1 vs. budesonide/formoterol BD at 24 weeks3

    Adapted from Lipson et al. 2017.3

    The co-primary endpoints of change from baseline in trough FEV1 and SGRQ score at Week 24 were both met in this study.3

  • In the landmark IMPACT trial, TRELEGY Ellipta offered statistically superior improvements in trough FEV1 vs. UMEC/VI at 52 weeks1 2

    Reproduced from GSK Data-on-File.2

    The annual rate of on-treatment moderate/severe COPD exacerbations (primary endpoint) was significantly reduced with TRELEGY Ellipta vs. FF/VI and UMEC/VI (p>0.001 for both comparators).1

  • IMPACT was the first Phase III, randomised, double-blind, parallel-group, multicentre, 52-week trial to assess the efficacy and safety of the single-inhaler Triple Therapy TRELEGY Ellipta vs. an ICS/LABA (FF/VI 92/22 mcg) and vs. a LAMA/LABA (UMEC/VI 55/22 mcg) in symptomatic patients on COPD maintenance treatments who had experienced at least one exacerbation in the last 12 months.1 5

    Primary endpoint1

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

    Other key endpoints4

    • Lung function: change from baseline in trough FEV1 at Week 524
    • Health-related quality of life: change from baseline in SGRQ score at Week 524

    Key inclusion criteria1 5

    Patients aged 40 years or older with COPD and a CAT score ≥10 with:

    • FEV1 <50% predicted and >1 moderate/severe exacerbations in the previous year, or
    • FEV1 ≥50% to <80% predicted and ≥2 moderate exacerbation 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 criteria1 5

    Patients were excluded if they had an of the following:

    • a current diagnosis of asthma or other respiratory disorders
    • pneumonia or other respiratory tract infection unresolved ≤14 days or ≤7 days, respectively, prior to screening
    • unresolved exacerbation ≤14 days prior to screening
    • oral/systemic corticosteroid use ≤30 days prior to screening
  • The efficacy and safety of TRELEGY Ellipta OD were compared in the FULFIL study with budesonide/formoterol (320/9 mcg) BD.3

    The FULFIL study was a Phase III, randomised, double-blind, double-dummy, parallel-group, multicentre, 24-week study. Patients underwent a 2-week run-in period, during which medications at screening were unchanged from their pre-study COPD maintenance therapy, followed by a 24-week treatment period.3

    A subset of 430 patients (TRELEGY Ellipta OD n=210, BUD/FOR (320/9 mcg) BD n=220) remained on blinded study treatment for up to 52 weeks (the EXT population). Efficacy endpoints and safety were assessed up to Week 52 in the EXT population.3

    Co-primary endpoints3

    • Change from baseline in trough FEV1 and SGRQ score at Week 24

    Some secondary/other endpoints3

    • Annual rate of moderate/severe COPD exacerbations
    • Change from baseline CAT score

    Key inclusion criteria3

    • Patients with COPD with FEV1 <50% and CAT score ≥10, or
    • Patients with FEV1 ≥50% to <80% and CAT score ≥10, and either ≥2 moderate exacerbations in the past year or ≥1 severe exacerbation in the past year
    • Aged ≥40 years old

    Key exclusion criteria3

    • Current diagnosis of asthma causing patient symptoms
    • Unresolved pneumonia or severe COPD exacerbation

Abbreviations:

BD, twice-daily; BUD, budesonide; CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; EXT, extension; 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; OD, once-daily; SGRQ, St George’s Respiratory Questionnaire; UMEC, umeclidinium; VI, vilanterol.

References:

  1. Lipson DA et al. N Engl J Med 2018; 378:1671–1680.
  2. GSK Data On File. RF/TLY/0067/18 IMPACT Study trough FEV1 data over 52 weeks.
  3. Lipson DA et al. Am J Respir Crit Care Med 2017; 196(4):438–446.
  4. Lipson DA et al. N Engl J Med 2018; 378:1671–1680 (supplementary material).
  5. Lipson DA et al. N Engl J Med 2018; 378:1671–1680 (supplementary material protocol).
  6. TRELEGY Ellipta SmPC, 2018. Available at www.medicines.ie. Accessed December 2018.
  7. Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) SmPC, 2018.
  8. Anoro▼ Ellipta (umeclidinium/vilanterol 55/22 mcg) SmPC, 2018.

TRELEGY Ellipta, Relvar Ellipta and Anoro Ellipta were developed in collaboration with INNOVIVA Inc.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse reactions can also be reported to the HPRA by calling (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

© 2018 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

TRELEGY Ellipta OD is indicated for maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an ICS and a LABA, or a combination of a LAMA and a LABA6

Relvar Ellipta (fluticasone furoate/vilanterol 92/22 mcg) is indicated for the symptomatic treatment of adults with COPD with a FEV1 <70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy7

Anoro Ellipta (umeclidinium/vilanterol 55/22 mcg) is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD8