Back to resultsEosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation (eo-Drive)
Primary Purpose
COPD Exacerbation
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
5 days of systemic corticotherapy (prednisone)
5 days of placebo
Sponsored by
About this trial
This is an interventional treatment trial for COPD Exacerbation
Eligibility 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
Sites / Locations
- CHU Amiens
- CHU Brest - Hôpital Caval BlancheRecruiting
- Clinique du Parc
- Centre hospitalier intercommunal de Créteil
- CH Libourne
- CHRU Lille
- Hospice Civils de LyonRecruiting
- APHM - Hôpital NordRecruiting
- CHU MontpellierRecruiting
- CHU NancyRecruiting
- CHU Nîmes
- APHP - Hopital Européen Georges PompidouRecruiting
- APHP - Hôpital BICHATRecruiting
- APHP - Hôpital CochinRecruiting
- APHP - Hôpital Universitaire Pitié-SalpétrièreRecruiting
- APHP - Hôpital Universitaire Pitié-Salpétrière
- CHU Bordeaux - Hôpital Haut LévêqueRecruiting
- CHU Reims
- CH Roubaix
- CHRU Strasbourg
- Hôpital Larrey CHU ToulouseRecruiting
- Hôpital Nord Franche-Comté
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Eosinophil count > 2%; corticotherapy
Eosinophil count <= 2%; corticotherapy
Eosinophil count > 2%; placebo
Eosinophil count <= 2%; placebo
Arm Description
Eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
Non-eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
Eosinophilic patients randomized to this arm will receive 5 days of placebo.
Non-eosinophilic patients randomized to this arm will receive 5 days of placebo.
Outcomes
Primary Outcome Measures
Treatment failure
Treatment failure for the primary outcome is defined according to Niewoehner et al. (1999) as death from any cause or need for intubation and mechanical ventilation, readmission due to COPD, or intensification of pharmacologic therapy (defined as the prescription of open-label systemic glucocorticoids, high-dose inhaled glucocorticoids (more than eight puffs per day of triamcinolone acetonide or its equivalent), theophylline, or any combination of these three therapies) at three months. In addition, an investigator meeting determined additional components of treatment failure that should be added to Niewoehner's definition in order to bring it up-to-date :
Initiation of non-invasive ventilation for >24h after first treatment administration
Transfer to intensive care or indication for a transfer to intensive care. Incident limitations-of-care that can affect treatment failure should also be carefully noted.
Secondary Outcome Measures
The speed of initial recovery: Time elapsed before showing signs of improvement
The speed of initial recovery: Time elapsed in acidosis/hypercapnia
The speed of initial recovery: Time elapsed before meeting pre-defined discharge criteria
Time elapsed before meeting pre-defined discharge criteria (acidosis has normalized, symptoms have returned to manageable levels, the patient is capable of performing minimal daily activities).
Presence /absence of comorbidities or steroid side effects: glycemia
Presence /absence of comorbidities or steroid side effects: glycemia
Presence /absence of comorbidities or steroid side effects: glycemia
The occurrence of new or worsened diabetes/hyperglycemia
Body mass index
Body mass index
Body mass index
Body mass index
Hospital anxiety and depression scale (HAD)
The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Hospital anxiety and depression scale (HAD)
The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
The occurrence of any other potentially corticosteroid-induced comorbidities throughout the study
Episodes of pneumonia
Beginning and end dates of episodes.
Episodes of infection
Beginning and end dates of episodes.
Episodes of mild exacerbation.
Episodes of exacerbation will be recorded (date of start/finish for each episode) throughout the study.
Exacerbation severity is determined (GOLD 2018) as follows:
mild: treated with short acting bronchodilators (SABDs) only,
moderate: treated with SABDs plus antibiotics and/or oral corticosteroids,
severe: patient required hospitalization or visits the emergency room.
Episodes of moderate exacerbation.
Episodes of exacerbation will be recorded (date of start/finish for each episode) throughout the study.
Exacerbation severity is determined (GOLD 2018) as follows:
mild: treated with short acting bronchodilators (SABDs) only,
moderate: treated with SABDs plus antibiotics and/or oral corticosteroids,
severe: patient required hospitalization or visits the emergency room.
Episodes of severe exacerbation.
Episodes of exacerbation will be recorded (date of start/finish for each episode) throughout the study.
Exacerbation severity is determined (GOLD 2018) as follows:
mild: treated with short acting bronchodilators (SABDs) only,
moderate: treated with SABDs plus antibiotics and/or oral corticosteroids,
severe: patient required hospitalization or visits the emergency room.
Forced expiratory volume in 1 second (litres)
Forced expiratory volume in 1 second (litres)
Forced expiratory volume in 1 second (% predicted)
Forced expiratory volume in 1 second (% predicted)
Forced vital capacity (litres)
Forced vital capacity (litres)
Forced vital capacity (% predicted)
Forced vital capacity (% predicted)
Residual volume (litres)
Residual volume (litres)
Residual volume (% predicted)
Residual volume (% predicted)
Total lung capacity (litres)
Total lung capacity (litres)
Total lung capacity (% predicted)
Total lung capacity (% predicted)
Oxygen needs (litres/min) during initial hospitalisation
Mode of pre-hospitalization living arrangements
At home, rehabilitation centre, assisted living centre, or other
Hospital discharge modality
At home, rehabilitation centre, assisted living centre, or other
Episodes of hospitalization
Episodes of hospitalization, distinguishing emergency department, intensive care, intermediate care and ward stays, will be recorded throughout the study .
Episodes of emergency department use
Episodes of intensive care
Consults
The number of consults and rehabilitation/therapy sessions in relation to COPD/respiratory symptoms (or not) will be tracked.
The cumulative days alive and event-free
The cumulative days alive and event-free (free from hospitalization, exacerbation, ventilation, oxygen use, pneumonia or infection)
Mortality/survival
Medications
Drug consumption episodes (including vaccines) will be recorded throughout the study and linked to COPD exacerbations, COPD maintenance therapy or corticosteroid-induced side effects as appropriate.
VAS scale for coughing
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for coughing
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for coughing
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for dyspnoea
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for dyspnoea
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for dyspnoea
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for sputum production
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for sputum production
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for sputum production
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for sleep perturbation
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for sleep perturbation
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for sleep perturbation
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for anxiety
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for anxiety
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
VAS scale for anxiety
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
The Breathlessness, Cough and Sputum Scale
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
The Breathlessness, Cough and Sputum Scale
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
The Breathlessness, Cough and Sputum Scale
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
The Breathlessness, Cough and Sputum Scale
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
The modified medical research council (mMRC) dyspnoea scale
Scores range from 0 (none) to 4 (very severe).
The modified medical research council (mMRC) dyspnoea scale
Scores range from 0 (none) to 4 (very severe).
The COPD assessment test
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
The COPD assessment test
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
The COPD assessment test
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
The Euroqol (EQ-5D-5L) questionnaire
The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The Euroqol (EQ-5D-5L) questionnaire
The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The Euroqol (EQ-5D-5L) questionnaire
The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The St George Respiratory Questionnaire
Scores range from 0 to 100, with higher scores indicating more limitations.
Six minute walking tests
Six minute walking tests
The DIRECT questionnaire
DIRECT: Disability related to Chronic Obstructive Pulmonary Disease (COPD) tool The DIRECT questionnaire provides a score ranging between 0 and 34, with higher values indicating higher levels of disability.
Full Information
NCT ID
NCT04234360
First Posted
January 13, 2020
Last Updated
September 19, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT04234360
Brief Title
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation
Acronym
eo-Drive
Official Title
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2021 (Actual)
Primary Completion Date
October 12, 2024 (Anticipated)
Study Completion Date
January 12, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD Exacerbation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a randomised (1:1), 2-parallel arm, double-blind trial comparing outcomes for a group of eosinophilic COPD patients (n=150) treated via corticotherapy versus a 2nd, similar group (n=150) treated via placebo. Secondarily, the same comparison (2x n=150) will be made for non-eosinophilic patients (totally excluding non-eosinophilic patients would potentially affect biomarker knowledge and subsequent care decisions, leading to bias).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Patients, investigators / outcome assessors / care givers and study staff are blinded to eosinophil / basophil / monocyte results and treatment allocation.
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eosinophil count > 2%; corticotherapy
Arm Type
Experimental
Arm Description
Eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
Arm Title
Eosinophil count <= 2%; corticotherapy
Arm Type
Experimental
Arm Description
Non-eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
Arm Title
Eosinophil count > 2%; placebo
Arm Type
Placebo Comparator
Arm Description
Eosinophilic patients randomized to this arm will receive 5 days of placebo.
Arm Title
Eosinophil count <= 2%; placebo
Arm Type
Placebo Comparator
Arm Description
Non-eosinophilic patients randomized to this arm will receive 5 days of placebo.
Intervention Type
Drug
Intervention Name(s)
5 days of systemic corticotherapy (prednisone)
Intervention Description
Patients randomized to this arm will receive 40 mg prednisone per os per day for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Intervention Type
Drug
Intervention Name(s)
5 days of placebo
Intervention Description
Patients randomized to this arm will receive an appropriate placebo per os for 5 days. Other aspects of standard, recommended care (e.g. antibiotherapy) are respected.
Primary Outcome Measure Information:
Title
Treatment failure
Description
Treatment failure for the primary outcome is defined according to Niewoehner et al. (1999) as death from any cause or need for intubation and mechanical ventilation, readmission due to COPD, or intensification of pharmacologic therapy (defined as the prescription of open-label systemic glucocorticoids, high-dose inhaled glucocorticoids (more than eight puffs per day of triamcinolone acetonide or its equivalent), theophylline, or any combination of these three therapies) at three months. In addition, an investigator meeting determined additional components of treatment failure that should be added to Niewoehner's definition in order to bring it up-to-date :
Initiation of non-invasive ventilation for >24h after first treatment administration
Transfer to intensive care or indication for a transfer to intensive care. Incident limitations-of-care that can affect treatment failure should also be carefully noted.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The speed of initial recovery: Time elapsed before showing signs of improvement
Time Frame
During initial hospitalization (expected maximum of 28 days)
Title
The speed of initial recovery: Time elapsed in acidosis/hypercapnia
Time Frame
During initial hospitalization (expected maximum of 28 days)
Title
The speed of initial recovery: Time elapsed before meeting pre-defined discharge criteria
Description
Time elapsed before meeting pre-defined discharge criteria (acidosis has normalized, symptoms have returned to manageable levels, the patient is capable of performing minimal daily activities).
Time Frame
During initial hospitalization (expected maximum of 28 days)
Title
Presence /absence of comorbidities or steroid side effects: glycemia
Time Frame
During initial hospitalization (expected maximum of 28 days)
Title
Presence /absence of comorbidities or steroid side effects: glycemia
Time Frame
1 month
Title
Presence /absence of comorbidities or steroid side effects: glycemia
Time Frame
3 months
Title
The occurrence of new or worsened diabetes/hyperglycemia
Time Frame
Throughout the study (3 months)
Title
Body mass index
Time Frame
Baseline (day 0)
Title
Body mass index
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Body mass index
Time Frame
1 month
Title
Body mass index
Time Frame
3 month
Title
Hospital anxiety and depression scale (HAD)
Description
The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Time Frame
baseline (day 0)
Title
Hospital anxiety and depression scale (HAD)
Description
The HAD results in a score ranging from 0 (low anxiety or depression) to 21 (strong anxiety or depression).
Time Frame
3 months
Title
The occurrence of any other potentially corticosteroid-induced comorbidities throughout the study
Time Frame
Throughout the study; 3 months
Title
Episodes of pneumonia
Description
Beginning and end dates of episodes.
Time Frame
Throughout the study; 3 months
Title
Episodes of infection
Description
Beginning and end dates of episodes.
Time Frame
Throughout the study; 3 months
Title
Episodes of mild exacerbation.
Description
Episodes of exacerbation will be recorded (date of start/finish for each episode) throughout the study.
Exacerbation severity is determined (GOLD 2018) as follows:
mild: treated with short acting bronchodilators (SABDs) only,
moderate: treated with SABDs plus antibiotics and/or oral corticosteroids,
severe: patient required hospitalization or visits the emergency room.
Time Frame
Throughout the study; 3 months
Title
Episodes of moderate exacerbation.
Description
Episodes of exacerbation will be recorded (date of start/finish for each episode) throughout the study.
Exacerbation severity is determined (GOLD 2018) as follows:
mild: treated with short acting bronchodilators (SABDs) only,
moderate: treated with SABDs plus antibiotics and/or oral corticosteroids,
severe: patient required hospitalization or visits the emergency room.
Time Frame
Throughout the study; 3 months
Title
Episodes of severe exacerbation.
Description
Episodes of exacerbation will be recorded (date of start/finish for each episode) throughout the study.
Exacerbation severity is determined (GOLD 2018) as follows:
mild: treated with short acting bronchodilators (SABDs) only,
moderate: treated with SABDs plus antibiotics and/or oral corticosteroids,
severe: patient required hospitalization or visits the emergency room.
Time Frame
Throughout the study; 3 months
Title
Forced expiratory volume in 1 second (litres)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Forced expiratory volume in 1 second (litres)
Time Frame
3 months
Title
Forced expiratory volume in 1 second (% predicted)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Forced expiratory volume in 1 second (% predicted)
Time Frame
3 months
Title
Forced vital capacity (litres)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Forced vital capacity (litres)
Time Frame
3 months
Title
Forced vital capacity (% predicted)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Forced vital capacity (% predicted)
Time Frame
3 months
Title
Residual volume (litres)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Residual volume (litres)
Time Frame
3 months
Title
Residual volume (% predicted)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Residual volume (% predicted)
Time Frame
3 months
Title
Total lung capacity (litres)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Total lung capacity (litres)
Time Frame
3 months
Title
Total lung capacity (% predicted)
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Total lung capacity (% predicted)
Time Frame
3 months
Title
Oxygen needs (litres/min) during initial hospitalisation
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Mode of pre-hospitalization living arrangements
Description
At home, rehabilitation centre, assisted living centre, or other
Time Frame
Baseline (day 0)
Title
Hospital discharge modality
Description
At home, rehabilitation centre, assisted living centre, or other
Time Frame
At hospital discharge (expected maximum of 28 days)
Title
Episodes of hospitalization
Description
Episodes of hospitalization, distinguishing emergency department, intensive care, intermediate care and ward stays, will be recorded throughout the study .
Time Frame
Throughout the study; 3 months
Title
Episodes of emergency department use
Time Frame
Throughout the study; 3 months
Title
Episodes of intensive care
Time Frame
Throughout the study; 3 months
Title
Consults
Description
The number of consults and rehabilitation/therapy sessions in relation to COPD/respiratory symptoms (or not) will be tracked.
Time Frame
Throughout the study; 3 months
Title
The cumulative days alive and event-free
Description
The cumulative days alive and event-free (free from hospitalization, exacerbation, ventilation, oxygen use, pneumonia or infection)
Time Frame
Throughout the study; 3 months
Title
Mortality/survival
Time Frame
Throughout the study; 3 months
Title
Medications
Description
Drug consumption episodes (including vaccines) will be recorded throughout the study and linked to COPD exacerbations, COPD maintenance therapy or corticosteroid-induced side effects as appropriate.
Time Frame
Throughout the study; 3 months
Title
VAS scale for coughing
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
Every morning during hospitalization (expected maximum of 28 days)
Title
VAS scale for coughing
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
1 month
Title
VAS scale for coughing
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
3 months
Title
VAS scale for dyspnoea
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
Every morning during hospitalization (expected maximum of 28 days)
Title
VAS scale for dyspnoea
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
1 month
Title
VAS scale for dyspnoea
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
3 months
Title
VAS scale for sputum production
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
Every morning during hospitalization (expected maximum of 28 days)
Title
VAS scale for sputum production
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
1 month
Title
VAS scale for sputum production
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
3 months
Title
VAS scale for sleep perturbation
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
Every morning during hospitalization (expected maximum of 28 days)
Title
VAS scale for sleep perturbation
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
1 month
Title
VAS scale for sleep perturbation
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
3 months
Title
VAS scale for anxiety
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
Every morning during hospitalization (expected maximum of 28 days)
Title
VAS scale for anxiety
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
1 month
Title
VAS scale for anxiety
Description
Patient reported, separate visual analogue scales (VAS) for coughing, dyspnoea (at rest), sputum production, sleep perturbation and anxiety.
VAS scales range from 0 (absence of symptoms) to 10 (strongest possible symptoms imaginable).
Time Frame
3 months
Title
The Breathlessness, Cough and Sputum Scale
Description
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
Time Frame
Baseline (day 0)
Title
The Breathlessness, Cough and Sputum Scale
Description
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
Time Frame
On hospital discharge (expected maximum of 28 days)
Title
The Breathlessness, Cough and Sputum Scale
Description
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
Time Frame
1 month
Title
The Breathlessness, Cough and Sputum Scale
Description
Symptoms are evaluated on a 5-point Likert-type scale ranging from 0 to 4, with higher scores indicating more severe symptoms.
Time Frame
3 months
Title
The modified medical research council (mMRC) dyspnoea scale
Description
Scores range from 0 (none) to 4 (very severe).
Time Frame
Baseline (day 0)
Title
The modified medical research council (mMRC) dyspnoea scale
Description
Scores range from 0 (none) to 4 (very severe).
Time Frame
3 months
Title
The COPD assessment test
Description
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time Frame
Baseline (day 0)
Title
The COPD assessment test
Description
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time Frame
1 month
Title
The COPD assessment test
Description
Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.
Time Frame
3 months
Title
The Euroqol (EQ-5D-5L) questionnaire
Description
The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
Baseline (day 0)
Title
The Euroqol (EQ-5D-5L) questionnaire
Description
The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
1 month
Title
The Euroqol (EQ-5D-5L) questionnaire
Description
The descriptive system has five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each described by five levels of intensity ("no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems or complete inability"). This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time Frame
3 months
Title
The St George Respiratory Questionnaire
Description
Scores range from 0 to 100, with higher scores indicating more limitations.
Time Frame
3 months
Title
Six minute walking tests
Time Frame
1 month (optional)
Title
Six minute walking tests
Time Frame
3 months
Title
The DIRECT questionnaire
Description
DIRECT: Disability related to Chronic Obstructive Pulmonary Disease (COPD) tool The DIRECT questionnaire provides a score ranging between 0 and 34, with higher values indicating higher levels of disability.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Blood differential
Time Frame
Baseline (day 0)
Title
Blood differential
Time Frame
day 2
Title
Blood differential
Time Frame
On hospital discharge (expected maximum of 28 days)
Title
Blood differential
Time Frame
1 month
Title
Blood differential
Time Frame
3 months
Title
C reactive protein
Time Frame
Baseline (day 0)
Title
C reactive protein
Time Frame
On hospital discharge (expected maximum of 28 days)
Title
Sputum bacteriological analysis (or nasal swab if no sputum)
Time Frame
Baseline (day 0)
Title
Nasal swab virology
Time Frame
Baseline (day 0)
Title
Computed tomography scan of lungs: presence/absence of consolidation
Time Frame
Baseline (day 0); optional
Title
Computed tomography scan of lungs: presence/absence of consolidation
Time Frame
3 months; optional
Title
Computed tomography scan of lungs: % emphysema
Time Frame
Baseline (day 0); optional
Title
Computed tomography scan of lungs: % emphysema
Time Frame
3 months; optional
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnaud BOURDIN
Phone
0033467336126
Email
a-bourdin@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud BOURDIN
Organizational Affiliation
a-bourdin@chu-montpellier.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire ANDREJAK
First Name & Middle Initial & Last Name & Degree
Claire ANDREJAK
Facility Name
CHU Brest - Hôpital Caval Blanche
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD
First Name & Middle Initial & Last Name & Degree
Marie GUEGAN
First Name & Middle Initial & Last Name & Degree
Francis COUTURAUD, MD
Facility Name
Clinique du Parc
City
Castelnau-le-Lez
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khuder ALAGHA
First Name & Middle Initial & Last Name & Degree
Khuder ALAGHA
Facility Name
Centre hospitalier intercommunal de Créteil
City
Créteil
Country
France
Individual Site Status
Withdrawn
Facility Name
CH Libourne
City
Libourne
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent PORTEL
First Name & Middle Initial & Last Name & Degree
Laurent PORTEL
Facility Name
CHRU Lille
City
Lille
Country
France
Individual Site Status
Withdrawn
Facility Name
Hospice Civils de Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles DEVOUASSOUX
First Name & Middle Initial & Last Name & Degree
Gilles DEVOUASSOUX, MD
Facility Name
APHM - Hôpital Nord
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal CHANEZ
First Name & Middle Initial & Last Name & Degree
Pascal CHANEZ, MD
Facility Name
CHU Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud BOURDIN
First Name & Middle Initial & Last Name & Degree
Arnaud BOURDIN, PhD
Facility Name
CHU Nancy
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne GUILLAUMOT
First Name & Middle Initial & Last Name & Degree
Anne GUILLAUMOT, MD
Facility Name
CHU Nîmes
City
Nîmes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie PLOUVIER
First Name & Middle Initial & Last Name & Degree
Nathalie PLOUVIER
Facility Name
APHP - Hopital Européen Georges Pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaud SOUMAGNE
First Name & Middle Initial & Last Name & Degree
Thibaud SOUMAGNE, MD
Facility Name
APHP - Hôpital BICHAT
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille TAILLE
First Name & Middle Initial & Last Name & Degree
Camille TAILLE, MD
Facility Name
APHP - Hôpital Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE
First Name & Middle Initial & Last Name & Degree
Nicolas ROCHE, MD
Facility Name
APHP - Hôpital Universitaire Pitié-Salpétrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morgane FAURE
First Name & Middle Initial & Last Name & Degree
Morgane FAURE, MD
Facility Name
APHP - Hôpital Universitaire Pitié-Salpétrière
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus GONZALEZ
First Name & Middle Initial & Last Name & Degree
Jesus GONZELEZ
Facility Name
CHU Bordeaux - Hôpital Haut Lévêque
City
Pessac
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maeva ZYSMAN
First Name & Middle Initial & Last Name & Degree
Maeva ZYSMAN, MD
Facility Name
CHU Reims
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaétan DESLEE
First Name & Middle Initial & Last Name & Degree
Gaetan DESLEE, MD
Facility Name
CH Roubaix
City
Roubaix
Country
France
Individual Site Status
Withdrawn
Facility Name
CHRU Strasbourg
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain KESSLER
First Name & Middle Initial & Last Name & Degree
Romain KESSLER, MD
Facility Name
Hôpital Larrey CHU Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA
First Name & Middle Initial & Last Name & Degree
Elise NOEL-SAVINA, MD
Facility Name
Hôpital Nord Franche-Comté
City
Trévenans
Country
France
Individual Site Status
Completed
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity.
Data will be made available to persons who address a reasonable dataset request to the sponsor coordinating team (c/o Dr Carey Suehs, Department of Medical Information, Hôpital La Colombière, 39 avenue Charles Flahault, 34295 Montpellier Cedex 5, France).
In accordance with French law, dataset usage requests must by approved by the French CNIL (Commission Nationale de l'Informatique et des Libertés : https://www.cnil.fr/professionnel) prior to access.
IPD Sharing Time Frame
Datasets (and accompanying analytic code) can be requested after the publication process has been completed.
The protocol, SAP and information materials will be made available in real-time (in as much as possible) on the study website at the Open Science Framework.
IPD Sharing Access Criteria
The conditions under which members of the public will be granted access to datasets are:
The data will be used/examined in a not-for-profit manner;
The data will not be used in an attempt to identify a participant or group of participants;
The user does not work for a private insurance company;
The data will not be used in support of any kind of private insurance policy or health penalties;
The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights;
The user will state why they wish to access the data.
The appropriate CNIL approval has been obtained by the user.
IPD Sharing URL
https://osf.io/9j7uk/
Citations:
PubMed Identifier
32611741
Citation
Suehs CM, Zysman M, Chenivesse C, Burgel PR, Couturaud F, Deslee G, Berger P, Raherison C, Devouassoux G, Brousse C, Roche N, Molimard M, Chinet T, Devillier P, Chanez P, Kessler R, Didier A, Martinat Y, Le Rouzic O, Bourdin A. Prioritising outcomes for evaluating eosinophil-guided corticosteroid therapy among patients with acute COPD exacerbations requiring hospitalisation: a Delphi consensus study. BMJ Open. 2020 Jul 1;10(7):e035811. doi: 10.1136/bmjopen-2019-035811.
Results Reference
background
Links:
URL
https://osf.io/9j7uk/
Description
eo-Drive on the Open Science Framework
Learn more about this trial
Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation
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