The objective of the study is to evaluate the efficacy of home High Flow Oxygen for the reduction of severe exacerbation following admission for a severe exacerbation of COPD or death against standard oxygen therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
406
HFOT will be delivered validated medical devices and established as follow: * Patient will be acclimatized to HFOT which will aim to achieve a flow of air of 30L/min at a temperature of 34°C using dedicated nasal canula. * Once patient acclimatized, oxygen will be entrained in the HFOT device at a flow that will aim to achieve a saturation \> 90%. An arterial blood gas will be performed with such oxygen delivery, flowrate and temperature to ensure a PaO2 ≥ 8kPa
LTOT delivery will be performed according to French guidelines
UHRouen
Rouen, France
RECRUITINGtime to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time frame: 12 months
time to death
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Saint-Georges Respiratory score
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Saint-Georges Respiratory score
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Saint-Georges Respiratory score
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using EuroQol-5D-5L score
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using EuroQol-5D-5L score
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using EuroQol-5D-5L score
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
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Health-related quality of life is evaluated using Hospital anxiety and depression scale
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Hospital anxiety and depression scale
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Hospital anxiety and depression scale
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Time frame: 12 months
Number of Adverse events
Imputability of Adverse events is evaluated by investigator
Time frame: 3 months
Number of Adverse events
Imputability of Adverse events is evaluated by investigator
Time frame: 6 months
Number of Adverse events
Imputability of Adverse events is evaluated by investigator
Time frame: 12 months