About this 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Current or previous treatment with home HFOT
Current treatment with home mechanical ventilation
Current treatment with home CPAP
Hospitalized during the last 2 weeks
Trial design
Parallel
Treatments tested in this trial
Added high-flow oxygen therapy
DeviceAdded 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
Other interventionStandard care with low-flow oxygen therapy in accordance with clinical routine.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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)
Rate of hospitalizations or death from all causes
Rate of hospitalizations or death from all causes assessed using nationwide registry data
Hospitalization rate from all causes
Hospitalization rate from all causes assessed using nationwide registry data
Hospitalization rate from respiratory disease
Hospitalization rate from respiratory disease assessed using nationwide registry data
Other outcomes
Patient preference for continuing the treatment
Patients' self-reported patient preference for continuing the treatment assessed using postal questionnaire.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Skane University Hospital
Lead sponsor
Uppsala University Hospital
Collaborator
Region Stockholm
Collaborator
Region Örebro County
Collaborator
Blekinge County Council Hospital
Collaborator
Blekinge Institute of Technology
Collaborator
Lund University
Collaborator
Region Östergötland
Collaborator
Vastra Gotaland Region
Collaborator
Region Västerbotten
Collaborator
Landstinget i Värmland
Collaborator
ResMed
Collaborator
Swedish Heart Lung Foundation
Collaborator
The Swedish Research Council
Collaborator