Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation (NCT04234360) | Clinical Trial Compass
TerminatedPhase 3
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation
Stopped: low enrollment at participating centers
France182 participantsStarted 2021-10-12
Plain-language summary
The primary objective of this study is to compare treatment failure rates between a group of eosinophilic (eosinophilia \> 2% on day 1 of hospitalization) patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo.
Secondarily, treatment failure rates will also be compared between a group of non-eosinophilic patients hospitalised for a COPD exacerbation treated via corticotherapy versus a similar group treated via placebo. Study arms will also be compared for additional aspects of efficacy and safety:
* speed of recovery during the initial hospitalization;
* corticosteroid side effects / induced comorbidities;
* changes in symptoms and episodes of exacerbation;
* pulmonary function, oxygen use and ventilation;
* patient trajectories and resource use (e.g. survival, consults, episodes of hospitalization, medications);
* drug consumption (especially as relates to COPD management, exacerbations and induced comorbidities);
* health status, quality of life, activity/disability;
* patient safety / adverse events in general.
Eosinophilia thresholds optimizing the prediction of corticosteroid response and COPD outcomes will be re-evaluated. The relationships between corticosteroid response and key biomarkers (e.g. infectious groups) will be thoroughly explored, including within eosinophil strata. Potential gender subgroups differences will also be evaluated.
Finally, in prevision of further exploratory studies, a biological collection and an imaging library will be created in association with this protocol. The biological collection will be used to explore the genetic basis and physiology linked with treatment response, gender and patient trajectories. The image library will be used as a platform for the exploration of new imaging markers developed, for example, via machine learning and affiliated techniques.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inclus…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before completing — can you help me understand why it was stopped early, and what that means for the reliability of any results it produced?
2The trial was testing whether eosinophil levels in the blood could be used to guide steroid treatment during a COPD flare-up — is checking my eosinophil count something that could still be relevant to how my own exacerbations are managed?
3Since this was a Phase 3 trial that didn't finish, is there other completed research on eosinophil-guided corticosteroid therapy for COPD that you'd consider more trustworthy for making decisions about my care?
4The trial measured 'treatment failure' as its main outcome — can you explain what treatment failure means in the context of a COPD hospitalization, and how that risk applies to my specific situation?
5Given that this trial is no longer recruiting, are there any currently active studies or standard-of-care approaches that take a personalized approach to steroid dosing during COPD exacerbations that might be worth exploring for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.