Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Long-term oxygen therapy; Other: High Flow Oxygen Therapy

• Registration Number: NCT05196698
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-30
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-19
• Study Start: 2022-08-26
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Primary Completion: 2026-08-26
• Study Completion: 2026-08-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

1. Patient with a diagnosis of COPD defined by GOLD guidelines

2. Admitted in hospital for AECOPD

3. 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

4. Patients affiliated or, beneficiary of a social security cover

5. Patient who has read and understood the information letter and signed the consent form

6. 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

7. For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)

Exclusion Criteria

1. Age <18 or > 85 years

2. Patient treated with chronic NIV with ongoing treatment

3. 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.

4. BMI > 35 kg/m2

5. Patient admitted for an acute COVID-19 infection

6. Hypercapnic respiratory failure justifying NIV defined as

   1. An Arterial Blood Gas (ABG) PaCO2 > 7 kPa in stable condition within 6 months
   2. Patients with ABG PaCO2 > 7 kPa at hospital discharge and that remained hypercapnic between 2- and 4-weeks following discharge

7. Pregnancy (blood pregnancy test positive) or lactation ongoing

8. Significant psychiatric disorder or dementia that would prevent adherence to study protocol

9. Tobacco use < 10 pack-year

10. Expected survival < 12 months due to any situation other than COPD disease

11. Refusal of high-flow oxygen therapy

12. Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

13. Patients already involved in a research protocol that would impact with the outcome measured in the current protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long-Term Oxygen Therapy	Long-term oxygen therapy	Control arm
High Flow Oxygen Therapy	High Flow Oxygen Therapy	-

Primary Outcome Measures

Name	Time	Method
time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease	12 months
time to death	12 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Health-related Quality of Life	12 months	Health-related quality of life is evaluated using Pittsburgh sleep quality index score
Number of Adverse events	12 months	Imputability of Adverse events is evaluated by investigator

Trial Locations

Locations (1)

UHRouen; 🇫🇷 Rouen, France