Ellipta pack shot with three molecules

INTREPID: Trelegy Ellipta vs. triple therapy delivered in multiple, non Ellipta inhalers

83% of COPD Triple Therapy patients in UK are managing once and twice daily dosing concurrently1

INTREPID is a randomised, open label, multicentre effectivensss study which expands upon the evidence from the FULFIL and IMPACT trials on the efficacy of using Trelegy to treat moderate to severe COPD.

The INTREPID study was a real world study which looked at the effectiveness of Trelegy compared to any approved ICS/LABA/LAMA combination in multiple non Ellipta inhalers.2

Hear from the author about the intrepid study.

  • COPD patients have a 31% increase in the odds of improving their health status with Trelegy vs triple therapy inhalers delivered in multiple, non-Ellipta inhalers.2

    Graph showing the primary endpoint results of INTREPID trial

    **Patients who modified their randomised treatment, changed pulmonary rehabilitation status, or started oxygen therapy also included.
    ‡Missing data was imputed using imputation based on randomised treatment arm characteristics assuming MAR.

    In two separate replicate 12 week randomised double-blind, non-inferiority COPD studies, no statistically significant differences were seen between Trelegy Ellipta vs BUD/FOR-TIO in the change from baseline in either SGRQ total score or CAT score or in the proportion of SGRQ total score responders or CAT score responders at week 12.4

    †BD budesonide/formoterol (BUD/FOR) 400/12 via metered-does inhaler plus OD tiotropium (TIO) 18 via HandiHaler.

  • Trelegy significantly improved lung function vs. the comparator arm2

    Graph showing the secondary endpoint results of INTREPID trial

    *Week 24 data was used regardless of whether patients discontinued/modified their randomised treatment. Treatment changed pulmonary rehab status or started oxygen therapy.

    MCID for FEV1= 100mls

Key trial design

  • INTREPID: Trelegy Ellipta vs triple therapy delivered in multiple non Ellipta inhalers. Phase IV, randomised, open label, multicentre effectiveness study.

    FULFIL study design

    Primary endpoint:

    • Proportion of CAT score responders at week 24

    Secondary endpoints

    • Change from baseline FEV1 at week 24, percentage of patients making at least one critical error at week 24 and treatment related adverse events.

    Population

    • ≥40 years of age 
    • Symptomatic COPD (CAT score ≥10 at screening) 
    • Receiving non-Ellipta maintenance therapy for 16 weeks prior to randomisation (ICS+LAMA+LABA; ICS+LABA; LAMA+LABA)
    • History of ≥1 COPD moderate/severe exacerbation* in the 3 years prior to randomisation.

    *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

Prescribing Information Links

Trelegy Ellipta prescribing information (PDF)

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

Abbreviations

BD, twice daily; BUD, budesonide; CAT, COPD assessment test; FEV1, forced expiratory volume in one second; FF/UMEC/VI, fluticasone furoate, umeclidinium, vilanterol; FOR, formoterol; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; LAMA, long-acting muscarinic antagonist; OD, once daily; ARR, absolute risk reduction

References

  1. IQVIA DRx Patients on Treatment, December 2020 - November 2021
  2. Halpin, D et al 2021. INTREPID: single-versus multiple-inhaler triple therapy for COPD in usual clinical practice. ERJ Open Research, pp.00950-2020. No.824
  3. Trelegy Ellipta SmPC
  4. Ferguson, G et al, 2020. Once daily single-inhaler versus twice daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomised controlled trials. Respiratory research ,21 (1):131

 

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.

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Trelegy Ellipta was developed in collaboration with

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March 2022 | PM-GB-FVU-WCNT-220001 (V1.0)