Clinical trial NCT05196698: Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
Official title: Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 406
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: time to first hospital admission for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
timeFrame: 12 months
measure: time to death
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 3 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 6 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 12 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 3 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 6 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 12 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 3 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 6 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 12 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 3 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 6 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 12 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 3 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 6 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 12 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 3 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 6 months
measure: Change from Baseline in Health-related Quality of Life
timeFrame: 12 months
measure: Number of Adverse events
timeFrame: 3 months
measure: Number of Adverse events
timeFrame: 6 months
measure: Number of Adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: UHRouen
Study officials:
affiliation: University Hospital, Rouen
name: Antoine CUVELIER, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP La Pitié Salpétrière
name: Maxime PATOUT, Dr
role: PRINCIPAL_INVESTIGATOR
References: