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

February 5, 2026 updated by: University Hospital, Rouen
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
406

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time Frame: 12 months
12 months
time to death
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Health-related Quality of Life
Time Frame: 3 months
Health-related quality of life is evaluated using Saint-Georges Respiratory score
3 months
Change from Baseline in Health-related Quality of Life
Time Frame: 6 months
Health-related quality of life is evaluated using Saint-Georges Respiratory score
6 months
Change from Baseline in Health-related Quality of Life
Time Frame: 12 months
Health-related quality of life is evaluated using Saint-Georges Respiratory score
12 months
Change from Baseline in Health-related Quality of Life
Time Frame: 3 months
Health-related quality of life is evaluated using EuroQol-5D-5L score
3 months
Change from Baseline in Health-related Quality of Life
Time Frame: 6 months
Health-related quality of life is evaluated using EuroQol-5D-5L score
6 months
Change from Baseline in Health-related Quality of Life
Time Frame: 12 months
Health-related quality of life is evaluated using EuroQol-5D-5L score
12 months
Change from Baseline in Health-related Quality of Life
Time Frame: 3 months
Health-related quality of life is evaluated using Hospital anxiety and depression scale
3 months
Change from Baseline in Health-related Quality of Life
Time Frame: 6 months
Health-related quality of life is evaluated using Hospital anxiety and depression scale
6 months
Change from Baseline in Health-related Quality of Life
Time Frame: 12 months
Health-related quality of life is evaluated using Hospital anxiety and depression scale
12 months
Change from Baseline in Health-related Quality of Life
Time Frame: 3 months
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
3 months
Change from Baseline in Health-related Quality of Life
Time Frame: 6 months
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
6 months
Change from Baseline in Health-related Quality of Life
Time Frame: 12 months
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
12 months
Change from Baseline in Health-related Quality of Life
Time Frame: 3 months
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
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 3 months
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
3 months
Change from Baseline in Health-related Quality of Life
Time Frame: 6 months
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
6 months
Change from Baseline in Health-related Quality of Life
Time Frame: 12 months
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
12 months
Number of Adverse events
Time Frame: 3 months
Imputability of Adverse events is evaluated by investigator
3 months
Number of Adverse events
Time Frame: 6 months
Imputability of Adverse events is evaluated by investigator
6 months
Number of Adverse events
Time Frame: 12 months
Imputability of Adverse events is evaluated by investigator
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maxime PATOUT, Dr, AP-HP La pitié Salpêtrière
  • Principal Investigator: Antoine CUVELIER, Pr, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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