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NCT05196698Recruiting

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
406 (estimated)
First submitted
30 Nov 2021
Start date
26 Aug 2022
Primary completion date
26 Aug 2026
Lead sponsor
University Hospital, Rouen
Diseases
COPD
NCT number
NCT05196698

What you commit to

  • Study type: Interventional
  • Planned participants: 406
  • From 26 Aug 2022 to the primary completion date, 26 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Refusal of high-flow oxygen therapy

Other illness

  • 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
  • Significant psychiatric disorder or dementia that would prevent adherence to study protocol
  • Expected survival \< 12 months due to any situation other than COPD disease

Age

  • Age \<18 or \> 85 years

Other

  • BMI \> 35 kg/m2
  • Pregnancy (blood pregnancy test positive) or lactation ongoing
  • Tobacco use \< 10 pack-year
  • 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

Who the study is looking for

  • 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)

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UHRouen
Coordinator of this site? Confirm its status
RouenFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.