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

Not Applicable

Recruiting

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

• Registration Number: NCT06247397
• Lead Sponsor: Skane University Hospital

Brief 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).

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 Timeline

• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-02-06
• Study First Posted: 2024-02-07
• Study Start: 2024-06-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 310

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow oxygen therapy	Added high-flow oxygen therapy	Intervention arm
Low-flow oxygen therapy	Standard care	Comparison arm

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Research Unit, Blekinge University of Technology; 🇸🇪 Karlskrona, Blekinge, Sweden

Department of Heart, Lung and Clinical Physiology, Örebro University Hospital; 🇸🇪 Örebro, Sweden