Using home high flow oxygen to reduce severe COPD flare-ups

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

This study tests if using high flow oxygen at home can help people with COPD have fewer severe flare-ups after leaving the hospital compared to regular oxygen therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 406 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 1 site (Rouen)
• Trial ID: NCT05196698 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of home high flow oxygen therapy compared to standard oxygen therapy in reducing severe exacerbations of Chronic Obstructive Pulmonary Disease (COPD) following hospital admission. Patients diagnosed with COPD and experiencing severe respiratory impairment will be enrolled after their hospital stay. The study aims to determine if high flow oxygen can lead to better outcomes in terms of exacerbation rates and overall patient health.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with COPD who have been hospitalized for acute exacerbations and meet specific respiratory impairment criteria.

Not a fit: Patients with mild COPD or those not requiring hospitalization for exacerbations may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the frequency of severe COPD exacerbations and improve patient quality of life.

How similar studies have performed: While there is ongoing research in oxygen therapies for COPD, this specific approach of home high flow oxygen therapy is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Rouen

• UHRouen — Rouen, France (Recruiting)

Study contacts

• Principal investigator: Antoine CUVELIER, Pr — University Hospital, Rouen
• Study coordinator: Antoine CUVELIER, Pr

Conditions Chronic Obstructive Pulmonary Disease