Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT05196698

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Led by University Hospital, Rouen · Updated on 2026-02-06

406

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of COPD according to GOLD guidelines
  • Admission to hospital for acute exacerbation of COPD (AECOPD)
  • Severe respiratory impairment defined by long-term oxygen therapy criteria: PaO2 < 7.3kPa or <8kPa with polycythemia, pulmonary hypertension, or right heart failure on room air, either previously or after clinical stabilization during hospitalization
  • Affiliated with or beneficiary of social security coverage
  • Able to read, understand information, and provide signed consent
  • Women of childbearing potential must use effective contraception for at least 1 month and have a negative blood pregnancy test at screening
  • Menopausal women must have confirmed diagnosis of menopause (amenorrhea for at least 12 months not medically induced)
Not Eligible

You will not qualify if you...

  • Age under 18 or over 85 years
  • Current treatment with chronic non-invasive ventilation (NIV)
  • Diagnosed obstructive sleep apnea (OSA) treated with CPAP, or screening indicating moderate to severe OSA (AHI > 30/h)
  • Body Mass Index (BMI) over 35 kg/m2
  • Hospital admission due to acute COVID-19 infection
  • Hypercapnic respiratory failure requiring NIV (PaCO2 > 7 kPa) in stable condition within 6 months or persistent after discharge
  • Pregnancy or ongoing lactation
  • Significant psychiatric disorder or dementia affecting study adherence
  • Tobacco use less than 10 pack-years
  • Expected survival less than 12 months due to causes other than COPD
  • Refusal of high-flow oxygen therapy
  • Legal imprisonment or under judicial protection
  • Participation in another research protocol affecting study outcomes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UHRouen

Rouen, France

Actively Recruiting

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Research Team

A

Antoine CUVELIER, Pr

CONTACT

A

Armelle GUIDOTTI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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