The HiLOT high-flow therapy trial| ResMed

The HiLOT trial

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

Home high-flow therapy (HFT) has been shown to reduce acute exacerbation rates and hospital admissions in patients with chronic pulmonary obstructive disease (COPD)1,2. 

With the need to grow the level of evidence on the benefits of  ome HFT, HiLOT aims to evaluate the effect of using home HFT with long-term oxygen therapy (LTOT) during one year in people with COPD or interstitial lung disease (ILD), vs using LTOT alone.

Study objectives

The main objective is to evaluate the impact of home HFT with LTOT on mortality and hospitalisations in patients with COPD. The trial will also evaluate the benefit(s) of home HFT with LTOT on quality of life and symptoms and assess the cost effectiveness, compliance and tolerance of the therapy.

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

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