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

Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation: a Double-blind, Randomized, Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: COPD Exacerbation
• Intervention / Treatment: Drug: 5 days of systemic corticotherapy (prednisone); Drug: 5 days of placebo

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Arnaud BOURDIN; Phone Number: 0033467336126; Email: a-bourdin@chu-montpellier.fr

Study Locations

• France
  • Amiens, France
    • Not yet recruiting
    • CHU Amiens
    • Contact: Claire ANDREJAK
    • Principal Investigator: Claire ANDREJAK
  • Brest, France
    • Recruiting
    • CHU Brest - Hôpital Caval Blanche
    • Contact: Marie GUEGAN
    • Principal Investigator: Francis COUTURAUD, MD
    • Contact: Francis COUTURAUD
  • Castelnau-le-Lez, France
    • Not yet recruiting
    • Clinique du Parc
    • Contact: Khuder ALAGHA
    • Principal Investigator: Khuder ALAGHA
  • Créteil, France
    • Withdrawn
    • Centre Hospitalier Intercommunal de Créteil
  • Libourne, France
    • Not yet recruiting
    • Ch Libourne
    • Contact: Laurent PORTEL
    • Principal Investigator: Laurent Portel
  • Lille, France
    • Withdrawn
    • CHRU Lille
  • Lyon, France
    • Recruiting
    • Hospice Civils de Lyon
    • Contact: Gilles DEVOUASSOUX
    • Principal Investigator: Gilles DEVOUASSOUX, MD
  • Marseille, France
    • Recruiting
    • Aphm - Hopital Nord
    • Contact: Pascal CHANEZ
    • Principal Investigator: Pascal CHANEZ, MD
  • Montpellier, France
    • Recruiting
    • CHU Montpellier
    • Contact: Arnaud BOURDIN
    • Principal Investigator: Arnaud BOURDIN, PhD
  • Nancy, France
    • Recruiting
    • Chu Nancy
    • Contact: Anne GUILLAUMOT
    • Principal Investigator: Anne GUILLAUMOT, MD
  • Nîmes, France
    • Not yet recruiting
    • CHU Nîmes
    • Contact: Nathalie PLOUVIER
    • Principal Investigator: Nathalie PLOUVIER
  • Paris, France
    • Recruiting
    • APHP - Hôpital Cochin
    • Principal Investigator: Nicolas ROCHE, MD
    • Contact: Nicolas ROCHE
  • Paris, France
    • Recruiting
    • APHP - Hôpital BICHAT
    • Contact: Camille TAILLE
    • Principal Investigator: Camille TAILLE, MD
  • Paris, France
    • Recruiting
    • APHP - Hôpital Universitaire Pitié-Salpétrière
    • Contact: Morgane FAURE
    • Principal Investigator: Morgane FAURE, MD
  • Paris, France
    • Recruiting
    • APHP - Hôpital Européen Georges Pompidou
    • Contact: Thibaud SOUMAGNE
    • Principal Investigator: Thibaud SOUMAGNE, MD
  • Paris, France
    • Not yet recruiting
    • APHP - Hôpital Universitaire Pitié-Salpétrière
    • Contact: Jesus GONZALEZ
    • Principal Investigator: Jesus GONZELEZ
  • Pessac, France
    • Recruiting
    • CHU Bordeaux - Hôpital Haut Lévêque
    • Principal Investigator: Maeva ZYSMAN, MD
    • Contact: Maeva ZYSMAN
  • Reims, France
    • Not yet recruiting
    • CHU Reims
    • Contact: Gaétan DESLEE
    • Principal Investigator: Gaetan DESLEE, MD
  • Roubaix, France
    • Withdrawn
    • CH Roubaix
  • Strasbourg, France
    • Not yet recruiting
    • CHRU Strasbourg
    • Principal Investigator: Romain KESSLER, MD
    • Contact: Romain KESSLER
  • Toulouse, France
    • Recruiting
    • Hopital Larrey CHU Toulouse
    • Principal Investigator: Elise NOEL-SAVINA, MD
    • Contact: Elise NOEL-SAVINA
  • Trévenans, France
    • Completed
    • Hôpital Nord Franche-Comté

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eosinophil count > 2%; corticotherapy; Eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.	Drug: 5 days of systemic corticotherapy (prednisone); 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.
Experimental: Eosinophil count <= 2%; corticotherapy; Non-eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.	Drug: 5 days of systemic corticotherapy (prednisone); 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.
Placebo Comparator: Eosinophil count > 2%; placebo; Eosinophilic patients randomized to this arm will receive 5 days of placebo.	Drug: 5 days of placebo; 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.
Placebo Comparator: Eosinophil count <= 2%; placebo; Non-eosinophilic patients randomized to this arm will receive 5 days of placebo.	Drug: 5 days of placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The speed of initial recovery: Time elapsed before showing signs of improvement		During initial hospitalization (expected maximum of 28 days)
The speed of initial recovery: Time elapsed in acidosis/hypercapnia		During initial hospitalization (expected maximum of 28 days)
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).	During initial hospitalization (expected maximum of 28 days)
Presence /absence of comorbidities or steroid side effects: glycemia		During initial hospitalization (expected maximum of 28 days)
Presence /absence of comorbidities or steroid side effects: glycemia		1 month
Presence /absence of comorbidities or steroid side effects: glycemia		3 months
The occurrence of new or worsened diabetes/hyperglycemia		Throughout the study (3 months)
Body mass index		Baseline (day 0)
Body mass index		At hospital discharge (expected maximum of 28 days)
Body mass index		1 month
Body mass index		3 month
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).	baseline (day 0)
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).	3 months
The occurrence of any other potentially corticosteroid-induced comorbidities throughout the study		Throughout the study; 3 months
Episodes of pneumonia	Beginning and end dates of episodes.	Throughout the study; 3 months
Episodes of infection	Beginning and end dates of episodes.	Throughout the study; 3 months
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.	Throughout the study; 3 months
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.	Throughout the study; 3 months
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.	Throughout the study; 3 months
Forced expiratory volume in 1 second (litres)		At hospital discharge (expected maximum of 28 days)
Forced expiratory volume in 1 second (litres)		3 months
Forced expiratory volume in 1 second (% predicted)		At hospital discharge (expected maximum of 28 days)
Forced expiratory volume in 1 second (% predicted)		3 months
Forced vital capacity (litres)		At hospital discharge (expected maximum of 28 days)
Forced vital capacity (litres)		3 months
Forced vital capacity (% predicted)		At hospital discharge (expected maximum of 28 days)
Forced vital capacity (% predicted)		3 months
Residual volume (litres)		At hospital discharge (expected maximum of 28 days)
Residual volume (litres)		3 months
Residual volume (% predicted)		At hospital discharge (expected maximum of 28 days)
Residual volume (% predicted)		3 months
Total lung capacity (litres)		At hospital discharge (expected maximum of 28 days)
Total lung capacity (litres)		3 months
Total lung capacity (% predicted)		At hospital discharge (expected maximum of 28 days)
Total lung capacity (% predicted)		3 months
Oxygen needs (litres/min) during initial hospitalisation		At hospital discharge (expected maximum of 28 days)
Mode of pre-hospitalization living arrangements	At home, rehabilitation centre, assisted living centre, or other	Baseline (day 0)
Hospital discharge modality	At home, rehabilitation centre, assisted living centre, or other	At hospital discharge (expected maximum of 28 days)
Episodes of hospitalization	Episodes of hospitalization, distinguishing emergency department, intensive care, intermediate care and ward stays, will be recorded throughout the study .	Throughout the study; 3 months
Episodes of emergency department use		Throughout the study; 3 months
Episodes of intensive care		Throughout the study; 3 months
Consults	The number of consults and rehabilitation/therapy sessions in relation to COPD/respiratory symptoms (or not) will be tracked.	Throughout the study; 3 months
The cumulative days alive and event-free	The cumulative days alive and event-free (free from hospitalization, exacerbation, ventilation, oxygen use, pneumonia or infection)	Throughout the study; 3 months
Mortality/survival		Throughout the study; 3 months
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.	Throughout the study; 3 months
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).	Every morning during hospitalization (expected maximum of 28 days)
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).	1 month
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).	3 months
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).	Every morning during hospitalization (expected maximum of 28 days)
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).	1 month
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).	3 months
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).	Every morning during hospitalization (expected maximum of 28 days)
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).	1 month
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).	3 months
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).	Every morning during hospitalization (expected maximum of 28 days)
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).	1 month
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).	3 months
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).	Every morning during hospitalization (expected maximum of 28 days)
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).	1 month
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).	3 months
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.	Baseline (day 0)
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.	On hospital discharge (expected maximum of 28 days)
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.	1 month
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.	3 months
The modified medical research council (mMRC) dyspnoea scale	Scores range from 0 (none) to 4 (very severe).	Baseline (day 0)
The modified medical research council (mMRC) dyspnoea scale	Scores range from 0 (none) to 4 (very severe).	3 months
The COPD assessment test	Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.	Baseline (day 0)
The COPD assessment test	Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.	1 month
The COPD assessment test	Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.	3 months
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.	Baseline (day 0)
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.	1 month
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.	3 months
The St George Respiratory Questionnaire	Scores range from 0 to 100, with higher scores indicating more limitations.	3 months
Six minute walking tests		1 month (optional)
Six minute walking tests		3 months
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.	3 months

Other Outcome Measures

Outcome Measure	Time Frame
Blood differential	Baseline (day 0)
Blood differential	day 2
Blood differential	On hospital discharge (expected maximum of 28 days)
Blood differential	1 month
Blood differential	3 months
C reactive protein	Baseline (day 0)
C reactive protein	On hospital discharge (expected maximum of 28 days)
Sputum bacteriological analysis (or nasal swab if no sputum)	Baseline (day 0)
Nasal swab virology	Baseline (day 0)
Computed tomography scan of lungs: presence/absence of consolidation	Baseline (day 0); optional
Computed tomography scan of lungs: presence/absence of consolidation	3 months; optional
Computed tomography scan of lungs: % emphysema	Baseline (day 0); optional
Computed tomography scan of lungs: % emphysema	3 months; optional

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Arnaud BOURDIN, a-bourdin@chu-montpellier.fr

Publications and helpful links

General Publications

• 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.

Helpful Links

• eo-Drive on the Open Science Framework

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Estimated): October 12, 2024
• Study Completion (Estimated): January 12, 2025

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: RECHMPL19_0069 UF 7771; 2019-002724-33 (EudraCT Number); LIC-18-18-0374 (Other Grant/Funding Number: French DGOS PHRC National 2018)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No