Chronic Obstructive Pulmonary DiseaseHIFAENCT05196698
Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
A study testing High Flow Oxygen Therapy and Long-term oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Rouen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High Flow Oxygen Therapy and Long-term oxygen therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteFrance
- Study dates
- 26 Aug 2022to 26 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High Flow Oxygen Therapy, Long-term oxygen therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flow Oxygen TherapyOther
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 therapyOther
LTOT delivery will be performed according to French guidelines
| Study group | Role | What they receive |
|---|---|---|
| High Flow Oxygen Therapy | Experimental | Not described Receives: Other: High Flow Oxygen Therapy |
| Long-Term Oxygen Therapy | Other | Control arm Receives: Other: Long-term oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Measured: 12 months
time to death
Measured: 12 months
Secondary outcomes (21)
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Saint-Georges Respiratory score
Measured: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Saint-Georges Respiratory score
Measured: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Saint-Georges Respiratory score
Measured: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using EuroQol-5D-5L score
Measured: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using EuroQol-5D-5L score
Measured: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using EuroQol-5D-5L score
Measured: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Hospital anxiety and depression scale
Measured: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Hospital anxiety and depression scale
Measured: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Hospital anxiety and depression scale
Measured: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
Measured: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
Measured: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Leicester Cough Questionnaire score
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Measured: 3 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Measured: 6 months
Change from Baseline in Health-related Quality of Life
Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Measured: 12 months
Number of Adverse events
Imputability of Adverse events is evaluated by investigator
Measured: 3 months
Number of Adverse events
Imputability of Adverse events is evaluated by investigator
Measured: 6 months
Number of Adverse events
Imputability of Adverse events is evaluated by investigator
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start26 Aug 2022
- Primary completion26 Aug 2026 (estimated)
- Study completion26 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine CUVELIER, Pr, Principal investigator, University Hospital, RouenMaxime PATOUT, Dr, Principal investigator, AP-HP La Pitié Salpétrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196698
- Sponsor's protocol ID
- 2019/0412/HP
- Acronym
- HIFAE
- Status last verified
- Feb 2026
- First submitted
- 30 Nov 2021
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT05196698
- Acronym / sponsor ID
- HIFAE / 2019/0412/HP
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 26 Aug 2026 (estimated)
- Study completion
- 26 Aug 2026 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow Oxygen Therapy | Experimental | Other: High Flow Oxygen Therapy |
| Long-Term Oxygen Therapy | Other | Other: Long-term oxygen therapyControl arm |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Flow Oxygen TherapyHFOT 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 | High Flow Oxygen Therapy |
| Long-term oxygen therapyLTOT delivery will be performed according to French guidelines | Other | Long-Term Oxygen Therapy |
Primary outcome
time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Time frame: 12 months
time to death
Time frame: 12 months
21 secondary outcomes
Change from Baseline in Health-related Quality of Life
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Time frame: 12 months
Change from Baseline in Health-related Quality of Life
Time frame: 3 months
Change from Baseline in Health-related Quality of Life
Time frame: 6 months
Change from Baseline in Health-related Quality of Life
Time frame: 12 months
Number of Adverse events
Time frame: 3 months
Number of Adverse events
Time frame: 6 months
Number of Adverse events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine CUVELIER, Pr principal investigator
University Hospital, Rouen
Maxime PATOUT, Dr principal investigator
AP-HP La Pitié Salpétrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Oxygen Therapy and Long-term oxygen therapy in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine CUVELIER, Pr (+33232889059, antoine.cuvelier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.