Clinical trial NCT06247397: Effect of HIgh-flow Therapy in Long-term Oxygen Therapy
Official title: Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Severe
Interstitial Lung Disease
Chronic Respiratory Failure With Hypoxia
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala University Hospital
name: Region Stockholm
name: Region Örebro County
name: Blekinge County Council Hospital
name: Blekinge Institute of Technology
name: Lund University
name: Region Östergötland
name: Vastra Gotaland Region
name: Region Västerbotten
name: Landstinget i Värmland
name: ResMed
name: Swedish Heart Lung Foundation
name: The Swedish Research Council
First posted: 2024-02-07
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Time to first hospitalization or death from all causes
timeFrame: 1 year
Secondary outcomes:
measure: Time to first all-cause hospitalization or all-cause death
timeFrame: 1 year
measure: Rate of hospitalizations or death from all causes
timeFrame: 1 year
measure: Hospitalization rate from all causes
timeFrame: 1 year
measure: Hospitalization rate from respiratory disease
timeFrame: 1 year
measure: Number of hospitalized days
timeFrame: 1 year
measure: Hospitalization rate from cardiovascular disease
timeFrame: 1 year
measure: Number of admissions to intensive care unit (ICU)
timeFrame: 1 year
measure: Number of days in ICU
timeFrame: 1 year
measure: Mortality rate from all causes
timeFrame: 1 year
measure: Mortality rate from respiratory disease
timeFrame: 1 year
measure: Mortality rate from cardiovascular disease
timeFrame: 1 year
measure: Time to first exacerbation
timeFrame: 1 year
measure: Number of exacerbations
timeFrame: 1 year
measure: Incidence of cardiovascular disease
timeFrame: 1 year
measure: Need for home mechanical ventilation
timeFrame: 1 year
measure: Rate of withdrawal of long-term oxygen therapy
timeFrame: 1 year
measure: Adverse events
timeFrame: 3 and 12 months
measure: Primary care utilization
timeFrame: 1 year
measure: Health-related quality of life
timeFrame: 3 and 12 months
measure: Health status
timeFrame: 3 and 12 months
measure: Breathlessness at exertion
timeFrame: 3 and 12 months
measure: Breathlessness
timeFrame: 3 and 12 months
measure: Sleep quality
timeFrame: 3 and 12 months
measure: Physical activity
timeFrame: 3 and 12 months
measure: Change in health status
timeFrame: 3 and 12 months
measure: Nasal symptoms
timeFrame: 3 and 12 months
Other outcomes:
measure: Patient preference for continuing the treatment
timeFrame: 3 and 12 months
Locations:
city: Karlskrona
country: Sweden
facility: Research Unit, Blekinge University of Technology
state: Blekinge
city: Örebro
country: Sweden
facility: Department of Heart, Lung and Clinical Physiology, Örebro University Hospital
Study officials:
affiliation: Skane University Hospital
name: Magnus Ekström, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: