Home High Flow Oxygen to Reduce Acute Exacerbation of COPD (HIFAE)

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 Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: High Flow Oxygen Therapy; Other: Long-term oxygen therapy

• Study Type: Interventional
• Enrollment (Estimated): 406
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine CUVELIER, Pr; Phone Number: +33232889059; Email: antoine.cuvelier@chu-rouen.fr
• Study Contact Backup: Name: Armelle GUIDOTTI; Phone Number: +33232888265; Email: armelle.guidotti@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • UHRouen
    • Contact: Antoine CUVELIER, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 β-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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Maxime PATOUT, Dr, AP-HP La pitié Salpêtrière; Principal Investigator: Antoine CUVELIER, Pr, University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2019/0412/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No