The study population corresponds to patients hospitalized for COPD exacerbation
Conditions
Interventions
Trade Name: prednisone
Product Name: prednisone
Pharmaceutical Form: Capsule
Other descriptive name: PREDNISONE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion 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: oPost-bronchodilator FEV1/FVC 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 • Minimum age: 40 years • Maximum age: 85 years • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • White blood cell formula already performed and distributed to implicated teams • Directives for limitation-of-care (“LATA” in French) already established
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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. ;Primary end point(s): The primary outcome is % treatment failure at 3 months ;Timepoint(s) of evaluation of this end point: 3 months;Main Objective: 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1)The speed of initial recovery 2)Presence /absence of comorbidities or steroid side effects 3)Exacerbations 4)Pulmonary function, oxygen and ventilation requirements 5)Patient trajectories 6) Médications 7) Symptoms, physical activity levels and quality of life 8) Targeted biomarkers;Timepoint(s) of evaluation of this end point: 1) During initial hospitalisation 2) Throughout the study, 3 months 3) Throughout the study, 3 months 4) At hospital discharge, and during follow-up at 3 months 5)Throughout the study 6)Throughout the study 7)Throughout the study, 3 months 8)Throughout the study, 3 months | — |
Countries
France
Contacts
Public ContactAnne Cadène
University Hospital of Montpellier
Outcome results
None listed