Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

NCT ID: NCT05196698

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-26
• Study Completion Date: 2026-08-26

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

High Flow Oxygen Therapy

Group Type: EXPERIMENTAL

High Flow Oxygen Therapy

Intervention Type: OTHER

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

Control arm

Group Type: OTHER

Long-term oxygen therapy

Intervention Type: OTHER

LTOT delivery will be performed according to French guidelines

Interventions

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

Intervention Type: OTHER

Long-term oxygen therapy

LTOT delivery will be performed according to French guidelines

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine CUVELIER, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Maxime PATOUT, Dr

Role: PRINCIPAL_INVESTIGATOR

AP-HP La Pitié Salpétrière

Locations

UHRouen

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Antoine CUVELIER, Pr

Role: CONTACT

antoine.cuvelier@chu-rouen.fr

+33232889059

Armelle GUIDOTTI

Role: CONTACT

armelle.guidotti@chu-rouen.fr

+33232888265

Facility Contacts

Antoine CUVELIER, Pr

Role: primary

Other Identifiers

2019/0412/HP

Identifier Type: -

Identifier Source: org_study_id