Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
HILOT
1 other identifier
interventional
310
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2024
CompletedFirst Posted
Study publicly available on registry
February 7, 2024
CompletedStudy Start
First participant enrolled
June 10, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 21, 2025
May 1, 2025
3.5 years
January 17, 2024
May 15, 2025
Conditions
Outcome Measures
Primary Outcomes (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)
1 year
Secondary Outcomes (26)
Time to first all-cause hospitalization or all-cause death
1 year
Rate of hospitalizations or death from all causes
1 year
Hospitalization rate from all causes
1 year
Hospitalization rate from respiratory disease
1 year
Number of hospitalized days
1 year
- +21 more secondary outcomes
Other Outcomes (1)
Patient preference for continuing the treatment
3 and 12 months
Study Arms (2)
High-flow oxygen therapy
EXPERIMENTALIntervention arm
Low-flow oxygen therapy
ACTIVE COMPARATORComparison arm
Interventions
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 care with low-flow oxygen therapy in accordance with clinical routine.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Skane University Hospitallead
- Uppsala University Hospitalcollaborator
- Region Stockholmcollaborator
- Region Örebro Countycollaborator
- Blekinge County Council Hospitalcollaborator
- Blekinge Institute of Technologycollaborator
- Lund Universitycollaborator
- Region Östergötlandcollaborator
- Vastra Gotaland Regioncollaborator
- Region Västerbottencollaborator
- Landstinget i Värmlandcollaborator
- ResMedcollaborator
- Swedish Heart Lung Foundationcollaborator
- The Swedish Research Councilcollaborator
Study Sites (2)
Research Unit, Blekinge University of Technology
Karlskrona, Blekinge County, 37185, Sweden
Department of Heart, Lung and Clinical Physiology, Örebro University Hospital
Örebro, 70185, Sweden
Related Publications (1)
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. doi: 10.1186/s13063-026-09488-8. Online ahead of print.
PMID: 41634827DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Ekström, MD, PhD
Skane University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Senior Lecturer
Study Record Dates
First Submitted
January 17, 2024
First Posted
February 7, 2024
Study Start
June 10, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
IPD cannot be shared due to restrictions in the current ethical approval. Pseudonymized IPD can be shared upon reasonable request and separate ethical approval.