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Recruiting NCT06247397

Effect of HIgh-flow Therapy in Long-term Oxygen Therapy

No phase Interventional Chronic Obstructive Pulmonary Disease Severe Interstitial Lung Disease Chronic Respiratory Failure With Hypoxia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Added high-flow oxygen therapy, Standard care.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease Severe, Interstitial Lung Disease, Chronic Respiratory Failure With Hypoxia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial

Overview

This is a registry-based, randomized, controlled clinical trial of the effect of added high-flow oxygen therapy (using the device Lumis HFT) during one year in people with long-term oxygen therapy (LTOT) for chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD).

Detailed description

This is a registry-based, randomized, controlled clinical trial of patients with LTOT for COPD or ILD recruited using the Swedish National Registry for Respiratory Failure (Swedevox) in collaboration with a research network within the Swedish Respiratory Society. The trial evaluates the effect of added high-flow oxygen therapy nighttime to the regular low-flow oxygen therapy compared with regular low-flow oxygen therapy alone up to one year.

The purpose of this project is to improve evidence-based treatment of people with chronic respiratory failure, currently about 2000 patients annually in Sweden, who have high risk of adverse events and mortality.

Interventions

  • Device Added high-flow oxygen therapy
    Added high-flow oxygen therapy using the device Lumis HFT during nighttime and at the patient's discretion daytime, with the usual care (low-flow oxygen therapy) the rest of the time.
  • Other Standard care
    Standard care with low-flow oxygen therapy in accordance with clinical routine.

Primary outcome measures

  • Time to first hospitalization or death from all causes [Time frame: 1 year]
Secondary outcome measures (12)
  • Time to first all-cause hospitalization or all-cause death [Time frame: 1 year]
  • Rate of hospitalizations or death from all causes [Time frame: 1 year]
  • Hospitalization rate from all causes [Time frame: 1 year]
  • Hospitalization rate from respiratory disease [Time frame: 1 year]
  • Number of hospitalized days [Time frame: 1 year]
  • Hospitalization rate from cardiovascular disease [Time frame: 1 year]
  • Number of admissions to intensive care unit (ICU) [Time frame: 1 year]
  • Number of days in ICU [Time frame: 1 year]
  • Mortality rate from all causes [Time frame: 1 year]
  • Mortality rate from respiratory disease [Time frame: 1 year]
  • Mortality rate from cardiovascular disease [Time frame: 1 year]
  • Time to first exacerbation [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Age 40 years or older
  • Ongoing LTOT: prescribed for at least 15 hours per day; and since at least 28 days as registered in Swedevox
  • COPD or ILD as main underlying reason for LTOT
  • Oxygen concentrator as stationary oxygen source in the home including night-time
  • Body mass index (BMI) < 35 kg/m2

Exclusion criteria

  • Current or previous treatment with home HFOT
  • Current treatment with home mechanical ventilation
  • Current treatment with home CPAP
  • Hospitalized during the last 2 weeks
  • Current smoking or contact with flames
  • Self-reported average use of the LTOT < 15h per day (24 hours)
  • PaCO2 (breathing air at rest) > 8 kPa
  • Strong clinical suspicion of obstructive sleep apnea (OSA) or obesity-related hypoventilation syndrome (OHS) (as judged by the responsible staff)
  • Inability to participate in the study procedures (as judged by the staff)
  • Not eligible for continuing LTOT due to other reason (as judged by the staff)
  • Expected survival less than 3 months (as judged by the staff)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Sweden · 2 centers
  • Research Unit, Blekinge University of Technology — Karlskrona
  • Department of Heart, Lung and Clinical Physiology, Örebro University Hospital — Örebro

Publications

  • Sundh J, Ljunggren M, Palm A, Lindberg E, Lavergne F, Weinreich UM, Ahmadi Z, Ekstrom M; HILOT Collaboration Group. Effect of HIgh-Flow Therapy in Long-Term Oxygen Therapy (HILOT): study protocol for a multicentre, registry-based, randomised clinical trial. Trials. 2026 Feb 4;27(1):177. doi: 10.1186/s13063-026-09488-8. PMID 41634827

Identifiers

NCT: NCT06247397 · HILOT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗