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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSkane University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard care

    Other intervention

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

Treatment groups

310 Participants
are divided into 2 treatment groups
Group A: High-flow oxygen therapyExperimental treatment 1 intervention
Group B: Low-flow oxygen therapyActive comparator 1 intervention

Trial outcomes

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)

Time frame
1 year

Secondary outcomes

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)

Time frame
1 year
2

Rate of hospitalizations or death from all causes

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

Time frame
1 year
3

Hospitalization rate from all causes

Hospitalization rate from all causes assessed using nationwide registry data

Time frame
1 year
4

Hospitalization rate from respiratory disease

Hospitalization rate from respiratory disease assessed using nationwide registry data

Time frame
1 year

Other outcomes

1

Patient preference for continuing the treatment

Patients' self-reported patient preference for continuing the treatment assessed using postal questionnaire.

Time frame
3 and 12 months

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