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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06247397
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Skane University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Magnus Ekström, MD, PhD
Principal Investigator Affiliation	Skane University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Obstructive Pulmonary Disease Severe, Interstitial Lung Disease, Chronic Respiratory Failure With Hypoxia

Additional Details

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.

Arms & Interventions

Arms

Experimental: High-flow oxygen therapy

Intervention arm

Active Comparator: Low-flow oxygen therapy

Comparison arm

Interventions

Device: - 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.

Other: - Standard care

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