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Can High-Flow oxygen at home prevent COPD Flare-Ups?

NCT ID NCT05196698

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using high-flow oxygen at home can reduce severe COPD attacks or death in 406 patients who have just been hospitalized for a flare-up. Participants receive either high-flow oxygen or standard oxygen therapy. The goal is to see if high-flow oxygen helps them stay out of the hospital longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
High Flow Oxygen Therapy
What this could lead to
If it works, this could offer a new way to prevent serious COPD attacks and improve quality of life at home.
What could go wrong
This is an early-stage study with no phase, so results are uncertain. The treatment may not reduce hospital visits or death more than standard oxygen.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 406 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UHRouen

    RECRUITING

    Rouen, France

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