NCT03890224 Respiratory Support in Chronic Obstructive Pulmonary Disease (COPD) Patients
| NCT ID | NCT03890224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinact |
| Condition | Chronic Obstructive Pulmonary Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2019-07-04 |
| Primary Completion | 2024-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2019-07-04 with a primary completion date of 2024-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The hypothesis of this study is that any of 3 modalities of home non- invasive ventilation (NIV) compared to 'no NIV' (=hospital NIV) will reduce re-admission to hospital or death in COPD patients who remain persistently hypercapnic following an exacerbation requiring NIV.
Eligibility Criteria
Inclusion Criteria: * 1\) Patients with COPD, GOLD C or D and Forced expiratory volume in one second (FEV1)\<65%; * 2\) AHRF (pH\<7,35 and PaCO2≥45mm Hg (≥6kPa) treated more than 24h with Ventilation (non-invasive or invasive); * 3\) 48h to 2 weeks with pH\>7.35, and PaCO2\>45 (\>6kPa) after NIV withdrawal, during daytime at rest without oxygen or ventilatory support (or with O2 if patients are not able to avoid O2 with immediate desaturation below 80%). Exclusion Criteria: 1. Patient treated with chronic NIV or continuous positive airway pressure (CPAP) device, with ongoing treatment; 2. Primary diagnosis of restrictive lung disease causing hypercapnia i.e. obesity hypoventilation and chest wall disease, however these patients will be included if the "FEV1/Forced vital capacity (FVC)" ratio is \<60% and the FEV1 \<50% if the predominant defect is considered to be obstructive by the center clinician; 3. BMI \> 35 kg/m2; 4. Sedative medication causing hypercapnia (\> 3 drugs or more than 20mg of morphine/day); 5. Polygraphic diagnosis of Obstructive Sleep Apnoea Syndrome (AHI\>30/h (French criteria); 6. Cognitive impairment that would prevent informed consent into the trial 7. Pregnancy; 8. Tobacco use \< 10 pack-year; 9. Psychiatric disease necessitating anti-psychotic medication, ongoing treatment for drug or alcohol addiction, persons of no fixed abode post-discharge; 10. Unstable coronary artery syndrome; 11. Age \<18 years; 12. Inability to comply with the protocol; 13. Expected survival\<12 months due to any situation other than COPD disease; 14. Duration of ICU stay\>10 days; 15. No affiliated to national health insurance; 16. Measure of legal protection (guardianship, wardship or judicial protection) for patients over the age of majority.
Contact & Investigator
Jesus Gonzalez, MD
PRINCIPAL INVESTIGATOR
Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,
Frequently Asked Questions
Who can join the NCT03890224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Obstructive Pulmonary Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03890224 currently recruiting?
Yes, NCT03890224 is actively recruiting participants. Contact the research team at angele.guilbot@multihealthgroup.com for enrollment information.
Where is the NCT03890224 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT03890224 clinical trial?
NCT03890224 is sponsored by Clinact. The principal investigator is Jesus Gonzalez, MD at Hôpital Pitié Salpêtrière-Charles Foix, Paris, France ,. The trial plans to enroll 400 participants.