Chronic Obstructive Pulmonary Disease Severe, Chronic Respiratory Failure With Hypoxia, Interstitial Lung Disease
Conditions
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.
Interventions
DEVICEAdded 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.
OTHERStandard care
Standard care with low-flow oxygen therapy in accordance with clinical routine.
Sponsors
Uppsala University Hospital
Region Stockholm
Region Örebro County
Blekinge County Council Hospital
Blekinge Institute of Technology
Lund University
Region Östergötland
Vastra Gotaland Region
Region Västerbotten
Landstinget i Värmland
ResMed
Swedish Heart Lung Foundation
The Swedish Research Council
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| Rate of hospitalizations or death from all causes | 1 year | Rate of hospitalizations or death from all causes assessed using nationwide registry data |
| Hospitalization rate from all causes | 1 year | Hospitalization rate from all causes assessed using nationwide registry data |
| 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 |
| 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 |
| Mortality rate from cardiovascular disease | 1 year | The mortality rate from cardiovascular disease 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 |
| 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 |
| Rate of withdrawal of long-term oxygen therapy | 1 year | Rate of withdrawal of long-term oxygen therapy assessed using nationwide registry data |
| Adverse events | 3 and 12 months | Self-reported adverse events since study start assessed using a postal questionnaire. |
| Primary care utilization | 1 year | Self-reported number of primary care contacts since the start of the study 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. |
| Health status | 3 and 12 months | Self-reported health status assessed using the and the COPD Assessment Test (CAT) questionnaire. |
| 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. |
| Incidence of cardiovascular disease | 1 year | Incidence of cardiovascular disease assessed using nationwide registry data |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient preference for continuing the treatment | 3 and 12 months | Patients' self-reported patient preference for continuing the treatment assessed using postal questionnaire. |
Countries
Sweden
Contacts
Primary ContactMagnus Ekström, MD, PhD
Outcome results
None listed