Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT)

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).

Study Overview

• Status: Recruiting
• Conditions: Interstitial Lung Disease; Chronic Respiratory Failure With Hypoxia; Chronic Obstructive Pulmonary Disease Severe
• Intervention / Treatment: Device: Added high-flow oxygen therapy; Other: Standard care

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.

• Study Type: Interventional
• Enrollment (Estimated): 310
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magnus Ekström, MD, PhD; Phone Number: +46 0455731000; Email: magnus.ekstrom@med.lu.se

Study Locations

• Sweden
  • Örebro, Sweden, 70185
    • Recruiting
    • Department of Heart, Lung and Clinical Physiology, Örebro University Hospital
    • Contact: Josefin Sundh, MD, PhD
  • Blekinge
    • Karlskrona, Blekinge, Sweden, 37185
      • Recruiting
      • Research Unit, Blekinge University of Technology
      • Contact: Magnus Ekström, MD, PhD; Email: magnus.ekstrom@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-flow oxygen therapy; Intervention arm	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.
Active Comparator: Low-flow oxygen therapy; Comparison arm	Other: Standard care; Standard care with low-flow oxygen therapy in accordance with clinical routine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1 year
Rate of hospitalizations or death from all causes	Rate of hospitalizations or death from all causes assessed using nationwide registry data	1 year
Hospitalization rate from all causes	Hospitalization rate from all causes assessed using nationwide registry data	1 year
Hospitalization rate from respiratory disease	Hospitalization rate from respiratory disease assessed using nationwide registry data	1 year
Number of hospitalized days	Number of hospitalized days from all-causes, respiratory and cardiovascular disease using nationwide registry data	1 year
Hospitalization rate from cardiovascular disease	Hospitalization rate from cardiovascular disease assessed using nationwide registry data	1 year
Number of admissions to intensive care unit (ICU)	Number of admissions to ICU assessed using nationwide registry data	1 year
Number of days in ICU	Number of days in ICU assessed using nationwide registry data	1 year
Mortality rate from all causes	The mortality rate from all causes assessed using nationwide registry data	1 year
Mortality rate from respiratory disease	The mortality rate from respiratory disease assessed using nationwide registry data	1 year
Mortality rate from cardiovascular disease	The mortality rate from cardiovascular disease assessed using nationwide registry data	1 year
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	1 year
Number of exacerbations	Number of exacerbations of all severity assessed using self-reported and registry data	1 year
Incidence of cardiovascular disease	Incidence of cardiovascular disease assessed using nationwide registry data	1 year
Need for home mechanical ventilation	Need for starting home mechanical ventilation assessed using nationwide registry data	1 year
Rate of withdrawal of long-term oxygen therapy	Rate of withdrawal of long-term oxygen therapy assessed using nationwide registry data	1 year
Adverse events	Self-reported adverse events since study start assessed using a postal questionnaire.	3 and 12 months
Primary care utilization	Self-reported number of primary care contacts since the start of the study assessed using a postal questionnaire.	1 year
Health-related quality of life	Self-reported health-related quality of life assessed using the EuroQol Five Dimensions - Five Levels (EQ5D-5L) questionnaire.	3 and 12 months
Health status	Self-reported health status assessed using the and the COPD Assessment Test (CAT) questionnaire.	3 and 12 months
Breathlessness at exertion	Self-reported exertional breathlessness assessed using the Dyspnoea Exertion Scale (DES) questionnaire.	3 and 12 months
Breathlessness	Self-reported breathlessness assessed using the Dyspnea-12 questionnaire.	3 and 12 months
Sleep quality	Self-reported sleep quality assessed using the modified Basic Nordic Sleep Questionnaire.	3 and 12 months
Physical activity	Self-reported level of physical activity assessed using the modified Grimby-Frändin questionnaire.	3 and 12 months
Change in health status	Self-reported change in perceived health status assessed using the Global Impression of Change (GIC) scale.	3 and 12 months
Nasal symptoms	Self-reported nasal symptoms assessed using the modified Björklund questionnaire.	3 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient preference for continuing the treatment	Patients' self-reported patient preference for continuing the treatment assessed using postal questionnaire.	3 and 12 months

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Collaborators: Lund University; The Swedish Research Council; ResMed; Vastra Gotaland Region; Region Östergötland; Region Stockholm; Region Örebro County; Region Västerbotten; Swedish Heart Lung Foundation; Uppsala University Hospital; Blekinge County Council Hospital; Blekinge Institute of Technology; Landstinget i Värmland
• Investigators: Principal Investigator: Magnus Ekström, MD, PhD, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 6, 2024
• First Posted (Actual): February 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoxia; Lung Diseases, Interstitial
• Other Study ID Numbers: HILOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD cannot be shared due to restrictions in the current ethical approval. Pseudonymized IPD can be shared upon reasonable request and separate ethical approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No