Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

NCT05196698 | Recruiting

• 1 other identifier: 2019/0412/HP
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  12 months

• time to death

  12 months

Secondary Outcomes (21)

• Change from Baseline in Health-related Quality of Life

  3 months

• Change from Baseline in Health-related Quality of Life

  6 months

• Change from Baseline in Health-related Quality of Life

  12 months

• Change from Baseline in Health-related Quality of Life

  3 months

• Change from Baseline in Health-related Quality of Life

  6 months

Study Arms (2)

High Flow Oxygen Therapy

EXPERIMENTAL

Other: High Flow Oxygen Therapy

Long-Term Oxygen Therapy

OTHER

Control arm

Other: Long-term oxygen therapy

Interventions

Long-term oxygen therapy OTHER

LTOT delivery will be performed according to French guidelines

Long-Term Oxygen Therapy

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

High Flow Oxygen Therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UHRouen

Rouen, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine CUVELIER, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

• Maxime PATOUT, Dr

  AP-HP La Pitié Salpétrière

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoine CUVELIER, Pr

CONTACT

+33232889059; antoine.cuvelier@chu-rouen.fr

Armelle GUIDOTTI

CONTACT

+33232888265; armelle.guidotti@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 19, 2022
• Study Start: August 26, 2022
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): August 26, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)