INTREPID: INvestigation of TRELEGY Effectiveness: Usual PractIce

  • Research type

    Research Study

  • Full title

    The Clinical Effectiveness of Fluticasone Furoate/UmeclidiniumBromide/Vilanterol in a Single Inhaler (TRELEGY ELLIPTA) when Compared with Non-ELLIPTA Multiple Inhaler Triple Therapies in COPD Patients within a Usual Care Setting.

  • IRAS ID

    236090

  • Contact name

    Lydia Demetriou

  • Contact email

    lydia.x.demetriou@gsk.com

  • Sponsor organisation

    GlaxoSmithKline

  • Eudract number

    2017-004369-29

  • Duration of Study in the UK

    1 years, 8 months, 9 days

  • Research summary

    GlaxoSmithKline (GSK) is conducting this study (206854) to test how effective a new medicine called Trelegy Ellipta is in treating patients with COPD compared to other medicines currently in use.

    COPD patients are commonly treated with an Inhaled corticosteroid (ICS) in combination with long acting β2-agonist (LABA) and/or Long-acting Muscarinic Antagonists (LAMAs). The 3 drugs prescribed together are known as ‘Triple Therapy’ and may be provided in one or more inhaler. In November 2017 Trelegy Ellipta received approval for use in Europe as a once daily inhaler, for the treatment of COPD, and contains all 3 medicines. It is believed that once-daily dosing may improve patient compliance and therefore management of their symptoms and disease.
    1500 participants will be enrolled in the UK and will be asked to attend 2 or 3 visits to a GP over the course of the study. Eligible COPD patients will be ≥40 years old taking multiple inhaler triple therapy. Following consent, they will either take the Trelegy Ellipta inhaler once daily or take their usual inhalers as prescribed by their GPfor 24 weeks. A computer will decide whether a participant will receive Trelegy Ellipta or their usual COPD medicines. All patients will be asked about their medical history and be asked to complete quality of life questionnaires at the visits. Some patients will also be asked to complete breathing tests (spirometry) and an assessment of how they use their inhalers. Between study visits, patients will receive usual care from their GP.
    Trademarks are owned by or licensed to the GSK Group of Companies. ©2017 GSK Group of Companies or its licensor.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    18/WM/0021

  • Date of REC Opinion

    19 Feb 2018

  • REC opinion

    Further Information Favourable Opinion