BridgeMD
New treatment option for Chronic Obstructive Pulmonary Disease
Official title Home High Flow Oxygen to Reduce Acute Exacerbation of COPD
ClinicalTrials.gov ID: NCT05196698
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join 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...
- PaO2 \< 7.3kPa or \<8kPa with polycythemia, pulmonary hypertension or right heart failure on room air after clinical stabilization during the index...
You likely can't join if
- Age \ 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...
- BMI \> 35 kg/m2
- Patient admitted for an acute COVID-19 infection
- Hypercapnic respiratory failure justifying NIV defined as
See the full eligibility criteria
- 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...
- For menopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit)
- Age \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.