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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Oxygen Therapy | Experimental |
| |
| Long-Term Oxygen Therapy | Other | Control arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Oxygen Therapy | Other | HFOT will be delivered validated medical devices and established as follow:
|
| Measure | Description | Time Frame |
|---|---|---|
| time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease | 12 months | |
| time to death | 12 months |
| 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 |
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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):
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine CUVELIER, Pr | Contact | +33232889059 | antoine.cuvelier@chu-rouen.fr | |
| Armelle GUIDOTTI | Contact | +33232888265 | armelle.guidotti@chu-rouen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine CUVELIER, Pr | University Hospital, Rouen | Principal Investigator |
| Maxime PATOUT, Dr | AP-HP La Pitié Salpétrière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHRouen | Recruiting | Rouen | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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|
| Long-term oxygen therapy | Other | LTOT delivery will be performed according to French guidelines |
|
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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |