Clinical effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol in usual practice: the COPD INTREPID study design

Sally Worsley, Neil Snowise, David M G Halpin, Dawn Midwinter, Afisi S Ismaila, Elaine Irving, Leah Sansbury, Maggie Tabberer, David Leather, Chris Compton, Sally Worsley, Neil Snowise, David M G Halpin, Dawn Midwinter, Afisi S Ismaila, Elaine Irving, Leah Sansbury, Maggie Tabberer, David Leather, Chris Compton

Abstract

Effectiveness studies complement conventional randomised controlled trials by providing a holistic view of treatments in the setting of usual clinical practice. We present the protocol for the ongoing INTREPID (INvestigation of TRelegy Effectiveness: usual PractIce Design; ClinicalTrials.gov identifier: NCT03467425) study, a randomised, open-label, 24-week effectiveness study of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI; Trelegy) delivered by the ELLIPTA inhaler versus non-ELLIPTA multiple-inhaler triple therapy in patients with chronic obstructive pulmonary disease (COPD) in usual practice settings. INTREPID was designed to provide evidence of FF/UMEC/VI effectiveness in patients with COPD managed in routine healthcare systems across multiple European countries. Between study initiation and end-of-study visits, patients will receive their medication and care as they would ordinarily receive it, from their usual healthcare provider at their usual healthcare centre. Study-specific intervention will be minimal. The primary end-point will be the proportion of COPD assessment test (CAT) responders, defined as a clinically meaningful improvement from baseline of ≥2 units, at week 24. The CAT was chosen as it provides health status information relevant to patients, physicians, health technology agencies and payers. Lung function (forced expiratory volume in 1 s) and critical inhaler errors will also be assessed in a subgroup of patients. The strengths and weaknesses of the protocol and some of the challenges associated with conducting this multicountry study, such as differences in healthcare systems and treatment practices across sites, will also be discussed.

Conflict of interest statement

Conflict of interest: S. Worsley is an employee of, and holds stock in, GlaxoSmithKline plc. Conflict of interest: N. Snowise is an employee of, and holds stock in, GlaxoSmithKline plc., holds shares in Vectura, and is a Visiting Senior Lecturer at the Faculty of Life Sciences and Medicine, King's College, London. Conflict of interest: D.M.G. Halpin reports personal fees from AstraZeneca, Chiesi, GlaxoSmithKline plc. and Pfizer and personal fees and nonfinancial support from Boehringer Ingelheim and Novartis, outside the submitted work. Conflict of interest: D. Midwinter is an employee of, and holds stock in, GlaxoSmithKline plc. Conflict of interest: A.S. Ismaila is a full-time employee of GlaxoSmithKline plc. and an unpaid, part-time professor at McMaster University. Conflict of interest: E. Irving holds stocks and shares in GlaxoSmithKline plc. R&D Ltd. Conflict of interest: L. Sansbury is an employee of, and holds stock in, GlaxoSmithKline plc. Conflict of interest: M. Tabberer is an employee of, and holds stock in, GlaxoSmithKline plc. Conflict of interest: D. Leather is an employee of, and holds stock in, GlaxoSmithKline plc. Conflict of interest: C. Compton is an employee of, and holds stock in, GlaxoSmithKline plc.

Copyright ©ERS 2019.

Figures

FIGURE 1
FIGURE 1
INTREPID study design. Only two study visits (baseline and week 24) will be required during the INTREPID study. FEV1 and critical error assessments will be conducted in select patient subgroups only. CAT: COPD assessment test; COPD: chronic obstructive pulmonary disease; FEV1: forced expiratory volume in 1 s; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; LAMA: long-acting muscarinic antagonist; R: randomisation. #: ICS/LAMA/LABA multiple-inhaler triple therapy, LAMA/LABA combination dual therapy or ICS/LABA combination dual therapy.
FIGURE 2
FIGURE 2
Recruitment models employed across countries. CRO: contract research organisation; DE: Germany; NL: the Netherlands; PI: principal investigator; PIC: patient identification centre; SP: Spain; SWE: Sweden; UK: United Kingdom.

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Source: PubMed

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