Information on the EPiC-HFT trial | ResMed

The EPiC-HFT trial

A man sleeping in bed while receiving home high-flow therapy treatment

This clinical trial aims to demonstrate the clinical and cost-utility of home high-flow therapy (HFT), assessing the viability of home HFT as a suitable therapy for patients who have previously been hospitalised due to severe chronic obstructive pulmonary disease (COPD) exacerbation.

Study objectives*

The main objective of the trial is to investigate whether home HFT improves 12-month admission-free survival times, following a severe exacerbation of COPD requiring hospitalisation.

Patient population

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Main inclusion criteria

• Patients admitted to hospital with an exacerbation of COPD
• Age 40-80 years with smoking history >10 pack years
• Patient’s forced expiratory volume in 1 second (FEV1) is <80% predicted
• Patient’s FEV1/forced vital capacity (FVC) < 0.7

Study details

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Study type

Prospective, multicentre, open-label, randomised, controlled trial with parallel groups.

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Primary investigators

Prof Nicholas Hart
Dr Patrick Murphy

Lane Fox Clinical Respiratory Physiology, Research Centre, St Thomas Hospital

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Sponsor

Guy’s and St Thomas’ Hospital NHS Foundation Trust

Study design

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502 patients randomised into two groups:
• Intervention: Usual care + Home HFT
• Control: Usual care

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The enrolment period will last 24 months, with a follow-up period of 12 months, for a total study duration of 36 months.

The study endpoints

Primary endpoint:
12-month all cause admission-free survival

Secondary endpoints:
• Patient reported outcome measures (CAT, PSQI, EQ-5D-5L)**
• Physiological effects of HFT
• Cost utility analysis

14 centres

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This content is intended for health professionals only
*For more information visit the investigator’s research page https://www.kcl.ac.uk/research/epic-hft

**AECOPD, acute exacerbation of chronic obstructive pulmonary disease; BMI, body mass index; CAT, computerised adaptive tests; COPD, chronic obstructive pulmonary disease; EPIC, exacerbation prevention in COPD using home high flow therapy; EQ-5D-5L, EuroQol 5-dimension, 5-level quality of life questionnaire; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; HFT, high flow therapy; NIV, non-invasive ventilation; OSA, obstructive sleep apnoea; PaCO2, partial pressure of carbon dioxide; PAP, positive airway pressure; PSQI, Pittsburgh sleep quality index.

Content last updated: 03/2024