Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

— HIFAE  

Official title:

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196698
• Other study ID #: 2019/0412/HP
• Status: Recruiting
• Phase: N/A
• Start date: August 26, 2022
• Est. completion date: August 26, 2026

Study information

• Verified date: May 2023
• Source: University Hospital, Rouen
• Contact: Antoine CUVELIER, Pr
• Phone: +33232889059
• Email: antoine.cuvelier[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: August 26, 2026
• Est. primary completion date: August 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patient with a diagnosis of COPD defined by GOLD guidelines

2. Admitted in hospital for AECOPD

3. 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

4. Patients affiliated or, beneficiary of a social security cover

5. Patient who has read and understood the information letter and signed the consent form

6. 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 ß-HCG negative at the screening visit, during the duration of the study

7. For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)

Exclusion Criteria:

1. Age <18 or > 85 years

2. Patient treated with chronic NIV with ongoing treatment

3. 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.

4. BMI > 35 kg/m2

5. Patient admitted for an acute COVID-19 infection

6. Hypercapnic respiratory failure justifying NIV defined as

1. An Arterial Blood Gas (ABG) PaCO2 > 7 kPa in stable condition within 6 months

2. Patients with ABG PaCO2 > 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge

7. Pregnancy (blood pregnancy test positive) or lactation ongoing

8. Significant psychiatric disorder or dementia that would prevent adherence to study protocol

9. Tobacco use < 10 pack-year

10. Expected survival < 12 months due to any situation other than COPD disease

11. Refusal of high-flow oxygen therapy

12. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

13. Patients already involved in a research protocol that would impact with the outcome measured in the current protocol

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• High Flow Oxygen Therapy
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
• Long-term oxygen therapy
LTOT delivery will be performed according to French guidelines

Locations

Country	Name	City	State
France	UHRouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease		12 months
Primary	time to death		12 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Saint-Georges Respiratory score	3 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Saint-Georges Respiratory score	6 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Saint-Georges Respiratory score	12 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using EuroQol-5D-5L score	3 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using EuroQol-5D-5L score	6 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using EuroQol-5D-5L score	12 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Hospital anxiety and depression scale	3 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Hospital anxiety and depression scale	6 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Hospital anxiety and depression scale	12 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Leicester Cough Questionnaire score	3 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Leicester Cough Questionnaire score	6 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Leicester Cough Questionnaire score	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Pittsburgh sleep quality index score	3 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Pittsburgh sleep quality index score	6 months
Secondary	Change from Baseline in Health-related Quality of Life	Health-related quality of life is evaluated using Pittsburgh sleep quality index score	12 months
Secondary	Number of Adverse events	Imputability of Adverse events is evaluated by investigator	3 months
Secondary	Number of Adverse events	Imputability of Adverse events is evaluated by investigator	6 months
Secondary	Number of Adverse events	Imputability of Adverse events is evaluated by investigator	12 months