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

Interstitial Lung Disease Clinical Trial

— HILOT  

Official title:

Effect of HIgh-flow Therapy in Long-term Oxygen Therapy (HILOT): A Multicenter, Registry-based, Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247397
• Other study ID #: HILOT
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: Skane University Hospital
• Contact: Magnus Ekström, MD, PhD
• Phone: 0455731000
• Email: magnus.ekstrom[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Severe
• Chronic Respiratory Failure With Hypoxia
• Hypoxia
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Sweden	Research Unit, Blekinge University of Technology	Karlskrona	Blekinge
Sweden	Department of Heart, Lung and Clinical Physiology, Örebro University Hospital	Örebro

Sponsors (14)

Lead Sponsor	Collaborator
Skane University Hospital	Blekinge County Council Hospital, Blekinge Institute of Technology, Landstinget i Värmland, Lund University, Region Örebro County, Region Östergötland, Region Stockholm, Region Västerbotten, ResMed, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala University Hospital, Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

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