Ireland
--:--IST
Recruiting Not applicable

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

NCT06247397 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2024-06-10
Last updated
2025-05-21

Condition(s) studied

Chronic Obstructive Pulmonary Disease SevereInterstitial Lung DiseaseChronic Respiratory Failure With Hypoxia

Investigational drug(s) / intervention(s)

Added high-flow oxygen therapyStandard care

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.

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

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • Time to first hospitalization or death from all causes — 1 year
    Time to first hospitalization or death from all causes during 1 year after randomization in people with COPD (assessed using nationwide registry data)

Trial sites (2)

FacilityCityRegionStatus
Research Unit, Blekinge University of Technology Karlskrona Blekinge County Recruiting
Department of Heart, Lung and Clinical Physiology, Örebro University Hospital Örebro Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06247397 on ClinicalTrials.gov ↗ ← All trials in Sweden