Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Recruiting now · Not applicable

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT05196698

Run by

University Hospital, Rouen

People needed

406

Starts

2022-08-26

Expected to finish

2026-08-26

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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)

You may not qualify if…

• 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
• 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

Where it is running

• UHRouen — Rouen, France (enrolling)

Full record on ClinicalTrials.gov

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