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| Name | Class |
|---|---|
| Uppsala University Hospital | OTHER |
| Region Stockholm | OTHER_GOV |
| Region Örebro County | OTHER |
| Blekinge County Council Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-flow oxygen therapy | Experimental | Intervention arm |
|
| Low-flow oxygen therapy | Active Comparator | Comparison arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Added high-flow oxygen therapy | Device | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magnus Ekström, MD, PhD | Contact | 0455731000 | +46 | magnus.ekstrom@med.lu.se |
| Name | Affiliation | Role |
|---|---|---|
| Magnus Ekström, MD, PhD | Skane University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit, Blekinge University of Technology | Recruiting | Karlskrona | Blekinge County | 37185 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41634827 | Derived | 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. |
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IPD cannot be shared due to restrictions in the current ethical approval. Pseudonymized IPD can be shared upon reasonable request and separate ethical approval.
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
| Blekinge Institute of Technology | OTHER |
| Lund University | OTHER |
| Region Östergötland | OTHER |
| Vastra Gotaland Region | OTHER_GOV |
| Region Västerbotten | OTHER_GOV |
| Landstinget i Värmland | OTHER |
| ResMed | INDUSTRY |
| Swedish Heart Lung Foundation | OTHER |
| The Swedish Research Council | OTHER_GOV |
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| Standard care | Other | Standard care with low-flow oxygen therapy in accordance with clinical routine. |
|
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 |
| Department of Heart, Lung and Clinical Physiology, Örebro University Hospital | Recruiting | Örebro | 70185 | Sweden |
|