The HiLOT trial
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 home 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
Main inclusion criteria*:
• COPD patients on LTOT
• ILD patients on LTOT
• BMI <35kg/m2
• > 40 years
Main exclusion criteria*:
• Current treatment with HFT, non-invasive ventilation or CPAP
• BMI > 35kg/m2
• Hospitalisation in the last 2 weeks
Study details
Study type
Prospective, multicentre, registry-based, randomised controlled trial with parallel groups
Primary investigators
Assoc. Professor Magnus Ekström, Department Respiratory Medicine, Skåne University Hospital Lund, Sweden
Sponsor
Skåne University Hospital Lund, Sweden
Study design
310** patients randomised in two groups:
The intervention group: Home HFT + LTOT
The control group: LTOT alone
The enrolment period will last 36 months, with a follow-up period of 12 months, for a total study duration of 48 months.
The study endpoints
Primary endpoint:
Time to first hospitalisation or all-cause death in the year following randomisation in COPD patients.
Secondary endpoints include:
• Symptoms
• Health-related quality of life
• Hospitalisations
• Exacerbations
• Cost effectiveness
Taking place across 10 centres
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Learn more: Home HFT for COPD
The expert’s voice
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*Please see https://www.clinicaltrials.gov/study/NCT06247397 for further information
**270 COPD patients and 40 ILD patients
- Storgaard LH, et al. Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure. Int J Chron Obstruct Pulmon Dis 2018;13:1195-1205. DOI : 10.2147/COPD.S159666
- Rea H, et al. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med 2010;104:525-533. DOI : 10.1016/j.rmed.2009.12.016V
Content last updated: 04/2024