Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation (eo-Drive)

  • STATUS
    Recruiting
  • End date
    Jan 12, 2025
  • participants needed
    600
  • sponsor
    University Hospital, Montpellier
Updated on 3 July 2022

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.

Details
Condition COPD Exacerbation
Treatment 5 days of systemic corticotherapy (prednisone), 5 days of placebo
Clinical Study IdentifierNCT04234360
SponsorUniversity Hospital, Montpellier
Last Modified on3 July 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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