Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05196698

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHRouen

Rouen, France

Location status: Recruiting

Location contact

Antoine CUVELIER, Pr

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

High Flow Oxygen Therapy

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

Other

LTOT delivery will be performed according to French guidelines

Primary outcomes

  1. time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

    Time frame: 12 months

  2. time to death

    Time frame: 12 months

Secondary outcomes

  1. Change from Baseline in Health-related Quality of Life

    Time frame: 3 months

    Health-related quality of life is evaluated using Saint-Georges Respiratory score

  2. Change from Baseline in Health-related Quality of Life

    Time frame: 6 months

    Health-related quality of life is evaluated using Saint-Georges Respiratory score

  3. Change from Baseline in Health-related Quality of Life

    Time frame: 12 months

    Health-related quality of life is evaluated using Saint-Georges Respiratory score

  4. Change from Baseline in Health-related Quality of Life

    Time frame: 3 months

    Health-related quality of life is evaluated using EuroQol-5D-5L score

  5. Change from Baseline in Health-related Quality of Life

    Time frame: 6 months

    Health-related quality of life is evaluated using EuroQol-5D-5L score

  6. Change from Baseline in Health-related Quality of Life

    Time frame: 12 months

    Health-related quality of life is evaluated using EuroQol-5D-5L score

  7. Change from Baseline in Health-related Quality of Life

    Time frame: 3 months

    Health-related quality of life is evaluated using Hospital anxiety and depression scale

  8. Change from Baseline in Health-related Quality of Life

    Time frame: 6 months

    Health-related quality of life is evaluated using Hospital anxiety and depression scale

  9. Change from Baseline in Health-related Quality of Life

    Time frame: 12 months

    Health-related quality of life is evaluated using Hospital anxiety and depression scale

  10. Change from Baseline in Health-related Quality of Life

    Time frame: 3 months

    Health-related quality of life is evaluated using Leicester Cough Questionnaire score

  11. Change from Baseline in Health-related Quality of Life

    Time frame: 6 months

    Health-related quality of life is evaluated using Leicester Cough Questionnaire score

  12. Change from Baseline in Health-related Quality of Life

    Time frame: 12 months

    Health-related quality of life is evaluated using Leicester Cough Questionnaire score

  13. Change from Baseline in Health-related Quality of Life

    Time frame: 3 months

    Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score

  14. Change from Baseline in Health-related Quality of Life

    Time frame: 6 months

    Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score

  15. Change from Baseline in Health-related Quality of Life

    Time frame: 12 months

    Health-related quality of life is evaluated using Chronic Obstructive Pulmonary Disease Assessments Test score

  16. Change from Baseline in Health-related Quality of Life

    Time frame: 3 months

    Health-related quality of life is evaluated using Pittsburgh sleep quality index score

  17. Change from Baseline in Health-related Quality of Life

    Time frame: 6 months

    Health-related quality of life is evaluated using Pittsburgh sleep quality index score

  18. Change from Baseline in Health-related Quality of Life

    Time frame: 12 months

    Health-related quality of life is evaluated using Pittsburgh sleep quality index score

  19. Number of Adverse events

    Time frame: 3 months

    Imputability of Adverse events is evaluated by investigator

  20. Number of Adverse events

    Time frame: 6 months

    Imputability of Adverse events is evaluated by investigator

  21. Number of Adverse events

    Time frame: 12 months

    Imputability of Adverse events is evaluated by investigator

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine CUVELIER, Pr

CONTACT

[email protected]

+33232889059

Armelle GUIDOTTI

CONTACT

[email protected]

+33232888265

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: HIFAE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2022
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.