Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Study Overview
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Brief Summary
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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.

Official Title
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Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: High Flow Oxygen Therapy
* Other: Long-term oxygen therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a diagnosis of COPD defined by GOLD guidelines Admitted in hospital for AECOPD With severe respiratory impairment defined by one of the following criteria (long-term oxygen therapy (LTOT) criteria): Previously established on long-term oxygen therapy according to the following criteria: PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heart failure on room air in stable condition Or PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension or right heart failure on room air after clinical stabilization during the index admission Patients affiliated or, beneficiary of a social security cover Patient who has read and understood the information letter and signed the consent form For woman of childbearing potential, use of an effective contraception (oestro-progestatives or intra-uterine device or tubal ligation) since at least 1 month and an blood pregnancy test by β-HCG negative at the screening visit, during the duration of the study For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit) Exclusion Criteria: Age <18 or > 85 years Patient treated with chronic NIV with ongoing treatment Patients diagnosed with obstructive sleep apnea (OSA) treated with CPAP. Diagnosis of OSA will be over-ruled in patient that had a previous overnight polygraphy. For patients who never had an overnight polygraphy, screening for OSA will be made using the STOP-BANG questionnaire. If the results of the STOP-BANG questionnaire (Appendix 1) is >3, an Apnea-link recording will be performed. If AHI>30/h, patient will be excluded. BMI > 35 kg/m2 Patient admitted for an acute COVID-19 infection Hypercapnic respiratory failure justifying NIV defined as An Arterial Blood Gas (ABG) PaCO2 > 7 kPa in stable condition within 6 months Patients with ABG PaCO2 > 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge Pregnancy (blood pregnancy test positive) or lactation ongoing Significant psychiatric disorder or dementia that would prevent adherence to study protocol Tobacco use < 10 pack-year Expected survival < 12 months due to any situation other than COPD disease Refusal of high-flow oxygen therapy Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision) Patients already involved in a research protocol that would impact with the outcome measured in the current protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Flow Oxygen Therapy<br> | Other: High Flow Oxygen Therapy<br>* 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<br>|
| Other: Long-Term Oxygen Therapy<br>Control arm | Other: Long-term oxygen therapy<br>* LTOT delivery will be performed according to French guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease |  | 12 months | 
| time to death |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Saint-Georges Respiratory score | 3 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Saint-Georges Respiratory score | 6 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Saint-Georges Respiratory score | 12 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using EuroQol-5D-5L score | 3 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using EuroQol-5D-5L score | 6 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using EuroQol-5D-5L score | 12 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Hospital anxiety and depression scale | 3 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Hospital anxiety and depression scale | 6 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Hospital anxiety and depression scale | 12 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Leicester Cough Questionnaire score | 3 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Leicester Cough Questionnaire score | 6 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Leicester Cough Questionnaire score | 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 | 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 | 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 | 12 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Pittsburgh sleep quality index score | 3 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Pittsburgh sleep quality index score | 6 months | 
| Change from Baseline in Health-related Quality of Life | Health-related quality of life is evaluated using Pittsburgh sleep quality index score | 12 months | 
| Number of Adverse events | Imputability of Adverse events is evaluated by investigator | 3 months | 
| Number of Adverse events | Imputability of Adverse events is evaluated by investigator | 6 months | 
| Number of Adverse events | Imputability of Adverse events is evaluated by investigator | 12 months |