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Chronic Obstructive Pulmonary Disease SevereHILOTNCT06247397

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

A study testing Added high-flow oxygen therapy in people with Chronic Obstructive Pulmonary Disease Severe and Interstitial Lung Disease, run by Skane University Hospital at 2 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Added high-flow oxygen therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
310 participants
Where
2 sitesSweden
Study dates
10 Jun 2024to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Magnus Ekström, MD, PhD contact

0455731000 ext. +46

magnus.ekstrom@med.lu.se

Sweden2 sites, 2 recruiting

  • Research Unit, Blekinge University of Technology

    Karlskrona, Blekinge County, 37185

    Magnus Ekström, MD, PhD, magnus.ekstrom@med.lu.se

    Recruiting

  • Department of Heart, Lung and Clinical Physiology, Örebro University Hospital

    Örebro, 70185

    Josefin Sundh, MD, PhD

    Recruiting

Other trials in Sweden

About this study

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

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).

Read the 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.

Being tested
Added high-flow oxygen therapy, Standard care
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Added high-flow oxygen therapyDevice

    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.

  • Standard careOther

    Standard care with low-flow oxygen therapy in accordance with clinical routine.

Study groups in NCT06247397
Study groupRoleWhat they receive
High-flow oxygen therapyExperimentalIntervention arm
Receives: Device: Added high-flow oxygen therapy
Low-flow oxygen therapyActive comparatorComparison arm
Receives: Other: Standard care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first hospitalization or death from all causes

    Time to first hospitalization or death from all causes during 1 year after randomization in people with COPD (assessed using nationwide registry data)

    Measured: 1 year

Secondary outcomes (26)

  1. Time to first all-cause hospitalization or all-cause death

    Time to first all-cause hospitalization or all-cause death in people with ILD (assessed using nationwide registry data)

    Measured: 1 year

  2. Rate of hospitalizations or death from all causes

    Rate of hospitalizations or death from all causes assessed using nationwide registry data

    Measured: 1 year

  3. Hospitalization rate from all causes

    Hospitalization rate from all causes assessed using nationwide registry data

    Measured: 1 year

  4. Hospitalization rate from respiratory disease

    Hospitalization rate from respiratory disease assessed using nationwide registry data

    Measured: 1 year

  5. Number of hospitalized days

    Number of hospitalized days from all-causes, respiratory and cardiovascular disease using nationwide registry data

    Measured: 1 year

  6. Hospitalization rate from cardiovascular disease

    Hospitalization rate from cardiovascular disease assessed using nationwide registry data

    Measured: 1 year

  7. Number of admissions to intensive care unit (ICU)

    Number of admissions to ICU assessed using nationwide registry data

    Measured: 1 year

  8. Number of days in ICU

    Number of days in ICU assessed using nationwide registry data

    Measured: 1 year

  9. Mortality rate from all causes

    The mortality rate from all causes assessed using nationwide registry data

    Measured: 1 year

  10. Mortality rate from respiratory disease

    The mortality rate from respiratory disease assessed using nationwide registry data

    Measured: 1 year

  11. Mortality rate from cardiovascular disease

    The mortality rate from cardiovascular disease assessed using nationwide registry data

    Measured: 1 year

  12. Time to first exacerbation

    Time to first exacerbation after randomisation, defined as time to first dispensed antibiotics and/or oral corticosteroids, ED-visit or hospitalization for exacerbation assessed using self-reported and registry data

    Measured: 1 year

  13. Number of exacerbations

    Number of exacerbations of all severity assessed using self-reported and registry data

    Measured: 1 year

  14. Incidence of cardiovascular disease

    Incidence of cardiovascular disease assessed using nationwide registry data

    Measured: 1 year

  15. Need for home mechanical ventilation

    Need for starting home mechanical ventilation assessed using nationwide registry data

    Measured: 1 year

  16. Rate of withdrawal of long-term oxygen therapy

    Rate of withdrawal of long-term oxygen therapy assessed using nationwide registry data

    Measured: 1 year

  17. Adverse events

    Self-reported adverse events since study start assessed using a postal questionnaire.

    Measured: 3 and 12 months

  18. Primary care utilization

    Self-reported number of primary care contacts since the start of the study assessed using a postal questionnaire.

    Measured: 1 year

  19. Health-related quality of life

    Self-reported health-related quality of life assessed using the EuroQol Five Dimensions - Five Levels (EQ5D-5L) questionnaire.

    Measured: 3 and 12 months

  20. Health status

    Self-reported health status assessed using the and the COPD Assessment Test (CAT) questionnaire.

    Measured: 3 and 12 months

  21. Breathlessness at exertion

    Self-reported exertional breathlessness assessed using the Dyspnoea Exertion Scale (DES) questionnaire.

    Measured: 3 and 12 months

  22. Breathlessness

    Self-reported breathlessness assessed using the Dyspnea-12 questionnaire.

    Measured: 3 and 12 months

  23. Sleep quality

    Self-reported sleep quality assessed using the modified Basic Nordic Sleep Questionnaire.

    Measured: 3 and 12 months

  24. Physical activity

    Self-reported level of physical activity assessed using the modified Grimby-Frändin questionnaire.

    Measured: 3 and 12 months

  25. Change in health status

    Self-reported change in perceived health status assessed using the Global Impression of Change (GIC) scale.

    Measured: 3 and 12 months

  26. Nasal symptoms

    Self-reported nasal symptoms assessed using the modified Björklund questionnaire.

    Measured: 3 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start10 Jun 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
310 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06247397
Sponsor's protocol ID
HILOT
Acronym
HILOT
Status last verified
May 2025
First submitted
17 Jan 2024
Last updated
21 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD cannot be shared due to restrictions in the current ethical approval. Pseudonymized IPD can be shared upon reasonable request and separate ethical approval.

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.

    PubMed 41634827

Questions about this trial

What is this clinical trial studying?

A study testing Added high-flow oxygen therapy in people with Chronic Obstructive Pulmonary Disease Severe and Interstitial Lung Disease, run by Skane University Hospital at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Magnus Ekström, MD, PhD (0455731000 ext. +46, magnus.ekstrom@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first hospitalization or death from all causes (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06247397, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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