Corticotherapy for COPD patients with high eosinophil levels
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial
This study tests if giving corticosteroids helps hospitalized COPD patients with high eosinophil levels recover better than those who don’t receive the treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | Benralizumab, reslizumab, mepolizumab, dupilumab |
| Locations | 22 sites (Amiens and 21 other locations) |
| Trial ID | NCT04234360 on ClinicalTrials.gov |
What this trial studies
This study aims to compare treatment failure rates in hospitalized patients with COPD exacerbations who have eosinophilia versus those without. Participants will receive either systemic corticotherapy or a placebo for five days. The study will also evaluate recovery speed, side effects, symptom changes, pulmonary function, and overall health outcomes. The goal is to determine the effectiveness of corticotherapy based on eosinophil levels in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults hospitalized for acute COPD exacerbations with eosinophilia greater than 2%.
Not a fit: Patients who do not have COPD or those with eosinophilia levels below 2% may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for COPD exacerbations based on eosinophil levels.
How similar studies have performed: Previous studies have shown varying success with corticosteroid treatments in COPD, but this specific focus on eosinophil-driven therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Adult patients admitted to a participating hospital (ward, ICU or emergency services) for an acute COPD exacerbation
* For patients with known COPD: COPD defined according to GOLD 2018 criteria: (1) Post-bronchodilator FEV1/FVC \< 70% of predicted values; (2) \> 10 pack years smoking history
* For incident COPD cases with no spirometric history: symptoms and exposure according to GOLD 2018 report will be considered for the diagnosis, but if the spirometric diagnosis is not confirmed during follow-up, then the patient will be excluded
* Signed consent has been obtained, or the appropriate emergency procedure (under French law) allows enrolment
* Subjects must be covered by public health insurance
* Patient available for 3 months of follow-up. Subjects must be able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
* Subject unable to read or write; language barrier
* Subject who is in a dependency or employment with the sponsor or investigator
* Pregnancy or lactation
* Patients who are prisoners or under other forms of judicial protection
* Patients under any kind of guardianship
* The patient has already participated in the present protocol
* The patient is participating in another interventional study or has done so in the past 3 months
* The patient is in an exclusion period determined by a previous study
* The patient has been taking long-term systemic corticosteroids for longer than 1 month prior to inclusion
* The patient has already received \> 1 mg/kg of systemic corticotherapy in the past 48h
* Intubated-ventilated patient
* Administration of oral experimental drug is impossible
* Cancer within the last 12 months
* Current diagnosis of Asthma
* T2-inflammation targeting biologics (Benralizumab, reslizumab, mepolizumab, dupilumab) treatment
* Admitted for any other reason including, but not limited to, pulmonary embolism, pneumothorax, heart failure
* Known allergy to corticosteroids
* Consideration of a potential negative drug interaction with corticosteroids (at the investigator's discretion)
* White blood cell formula already performed and distributed to implicated teams
* Directives for limitation-of-care ("LATA" in French) already established
* SARS-Cov2 positive test carry out during the COPD exacerbation
Where this trial is running
Amiens and 21 other locations
- CHU Amiens — Amiens, France (Not_yet_recruiting)
- CHU Brest - Hôpital Caval Blanche — Brest, France (Recruiting)
- Clinique du Parc — Castelnau-le-Lez, France (Not_yet_recruiting)
- Centre hospitalier intercommunal de Créteil — Créteil, France (Withdrawn)
- CH Libourne — Libourne, France (Not_yet_recruiting)
- CHRU Lille — Lille, France (Withdrawn)
- Hospice Civils de Lyon — Lyon, France (Recruiting)
- APHM - Hôpital Nord — Marseille, France (Recruiting)
- CHU Montpellier — Montpellier, France (Recruiting)
- CHU Nancy — Nancy, France (Recruiting)
- CHU Nîmes — Nîmes, France (Not_yet_recruiting)
- APHP - Hopital Européen Georges Pompidou — Paris, France (Recruiting)
- APHP - Hôpital BICHAT — Paris, France (Recruiting)
- APHP - Hôpital Cochin — Paris, France (Recruiting)
- APHP - Hôpital Universitaire Pitié-Salpétrière — Paris, France (Recruiting)
- APHP - Hôpital Universitaire Pitié-Salpétrière — Paris, France (Not_yet_recruiting)
- CHU Bordeaux - Hôpital Haut Lévêque — Pessac, France (Recruiting)
- CHU Reims — Reims, France (Not_yet_recruiting)
- CH Roubaix — Roubaix, France (Withdrawn)
- CHRU Strasbourg — Strasbourg, France (Not_yet_recruiting)
- Hôpital Larrey CHU Toulouse — Toulouse, France (Recruiting)
- Hôpital Nord Franche-Comté — Trévenans, France (Completed)
Study contacts
- Principal investigator: Arnaud BOURDIN — a-bourdin@chu-montpellier.fr
- Study coordinator: Arnaud BOURDIN
- Email: a-bourdin@chu-montpellier.fr
- Phone: 0033467336126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.