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COPD ExacerbationPhase 3eo-DriveNCT04234360

Eosinophil-driven Corticotherapy for Patients Hospitalized for COPD Exacerbation

A Phase 3 study testing 5 days of systemic corticotherapy (prednisone) in people with COPD Exacerbation, run by University Hospital, Montpellier at 18 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
COPD Exacerbation
What is being tested?
5 days of systemic corticotherapy (prednisone)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
182 participants
Where
18 sitesFrance
Study dates
12 Oct 2021to 30 Jan 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

France18 sites

  • CHU Amiens

    Amiens

  • CHU Brest - Hôpital Caval Blanche

    Brest

  • Clinique du Parc

    Castelnau-le-Lez

  • CH Libourne

    Libourne

  • Hospice Civils de Lyon

    Lyon

  • APHM - Hôpital Nord

    Marseille

  • CHU Montpellier

    Montpellier

  • CHU Nancy

    Nancy

  • CHU Nîmes

    Nîmes

  • APHP - Hopital Européen Georges Pompidou

    Paris

  • APHP - Hôpital BICHAT

    Paris

  • APHP - Hôpital Cochin

    Paris

  • APHP - Hôpital Universitaire Pitié-Salpétrière

    Paris

  • CHU Bordeaux - Hôpital Haut Lévêque

    Pessac

  • CHU Reims

    Reims

  • CHRU Strasbourg

    Strasbourg

  • Hôpital Larrey CHU Toulouse

    Toulouse

  • Hôpital Nord Franche-Comté

    Trévenans

Other trials in France

About this study

Official title: 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:

Read more
  • 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.

Being tested
5 days of systemic corticotherapy (prednisone), 5 days of placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5 days of systemic corticotherapy (prednisone)Drug

    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.

  • 5 days of placeboDrug

    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.

Study groups in NCT04234360
Study groupRoleWhat they receive
Eosinophil count > 2%; corticotherapyExperimentalEosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
Receives: Drug: 5 days of systemic corticotherapy (prednisone)
Eosinophil count <= 2%; corticotherapyExperimentalNon-eosinophilic patients randomized to this arm will receive 5 days of corticotherapy.
Receives: Drug: 5 days of systemic corticotherapy (prednisone)
Eosinophil count > 2%; placeboPlacebo comparatorEosinophilic patients randomized to this arm will receive 5 days of placebo.
Receives: Drug: 5 days of placebo
Eosinophil count <= 2%; placeboPlacebo comparatorNon-eosinophilic patients randomized to this arm will receive 5 days of placebo.
Receives: Drug: 5 days of placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (76)

  1. The speed of initial recovery: Time elapsed before showing signs of improvement

    Measured: During initial hospitalization (expected maximum of 28 days)

  2. The speed of initial recovery: Time elapsed in acidosis/hypercapnia

    Measured: During initial hospitalization (expected maximum of 28 days)

  3. 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).

    Measured: During initial hospitalization (expected maximum of 28 days)

  4. Presence /absence of comorbidities or steroid side effects: glycemia

    Measured: During initial hospitalization (expected maximum of 28 days)

  5. Presence /absence of comorbidities or steroid side effects: glycemia

    Measured: 1 month

  6. Presence /absence of comorbidities or steroid side effects: glycemia

    Measured: 3 months

  7. The occurrence of new or worsened diabetes/hyperglycemia

    Measured: Throughout the study (3 months)

  8. Body mass index

    Measured: Baseline (day 0)

  9. Body mass index

    Measured: At hospital discharge (expected maximum of 28 days)

  10. Body mass index

    Measured: 1 month

  11. Body mass index

    Measured: 3 month

  12. 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).

    Measured: baseline (day 0)

  13. 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).

    Measured: 3 months

  14. The occurrence of any other potentially corticosteroid-induced comorbidities throughout the study

    Measured: Throughout the study; 3 months

  15. Episodes of pneumonia

    Beginning and end dates of episodes.

    Measured: Throughout the study; 3 months

  16. Episodes of infection

    Beginning and end dates of episodes.

    Measured: Throughout the study; 3 months

  17. 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.

    Measured: Throughout the study; 3 months

  18. 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.

    Measured: Throughout the study; 3 months

  19. 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.

    Measured: Throughout the study; 3 months

  20. Forced expiratory volume in 1 second (litres)

    Measured: At hospital discharge (expected maximum of 28 days)

  21. Forced expiratory volume in 1 second (litres)

    Measured: 3 months

  22. Forced expiratory volume in 1 second (% predicted)

    Measured: At hospital discharge (expected maximum of 28 days)

  23. Forced expiratory volume in 1 second (% predicted)

    Measured: 3 months

  24. Forced vital capacity (litres)

    Measured: At hospital discharge (expected maximum of 28 days)

  25. Forced vital capacity (litres)

    Measured: 3 months

  26. Forced vital capacity (% predicted)

    Measured: At hospital discharge (expected maximum of 28 days)

  27. Forced vital capacity (% predicted)

    Measured: 3 months

  28. Residual volume (litres)

    Measured: At hospital discharge (expected maximum of 28 days)

  29. Residual volume (litres)

    Measured: 3 months

  30. Residual volume (% predicted)

    Measured: At hospital discharge (expected maximum of 28 days)

  31. Residual volume (% predicted)

    Measured: 3 months

  32. Total lung capacity (litres)

    Measured: At hospital discharge (expected maximum of 28 days)

  33. Total lung capacity (litres)

    Measured: 3 months

  34. Total lung capacity (% predicted)

    Measured: At hospital discharge (expected maximum of 28 days)

  35. Total lung capacity (% predicted)

    Measured: 3 months

  36. Oxygen needs (litres/min) during initial hospitalisation

    Measured: At hospital discharge (expected maximum of 28 days)

  37. Mode of pre-hospitalization living arrangements

    At home, rehabilitation centre, assisted living centre, or other

    Measured: Baseline (day 0)

  38. Hospital discharge modality

    At home, rehabilitation centre, assisted living centre, or other

    Measured: At hospital discharge (expected maximum of 28 days)

  39. Episodes of hospitalization

    Episodes of hospitalization, distinguishing emergency department, intensive care, intermediate care and ward stays, will be recorded throughout the study .

    Measured: Throughout the study; 3 months

  40. Episodes of emergency department use

    Measured: Throughout the study; 3 months

  41. Episodes of intensive care

    Measured: Throughout the study; 3 months

  42. Consults

    The number of consults and rehabilitation/therapy sessions in relation to COPD/respiratory symptoms (or not) will be tracked.

    Measured: Throughout the study; 3 months

  43. The cumulative days alive and event-free

    The cumulative days alive and event-free (free from hospitalization, exacerbation, ventilation, oxygen use, pneumonia or infection)

    Measured: Throughout the study; 3 months

  44. Mortality/survival

    Measured: Throughout the study; 3 months

  45. 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.

    Measured: Throughout the study; 3 months

  46. 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).

    Measured: Every morning during hospitalization (expected maximum of 28 days)

  47. 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).

    Measured: 1 month

  48. 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).

    Measured: 3 months

  49. 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).

    Measured: Every morning during hospitalization (expected maximum of 28 days)

  50. 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).

    Measured: 1 month

  51. 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).

    Measured: 3 months

  52. 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).

    Measured: Every morning during hospitalization (expected maximum of 28 days)

  53. 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).

    Measured: 1 month

  54. 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).

    Measured: 3 months

  55. 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).

    Measured: Every morning during hospitalization (expected maximum of 28 days)

  56. 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).

    Measured: 1 month

  57. 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).

    Measured: 3 months

  58. 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).

    Measured: Every morning during hospitalization (expected maximum of 28 days)

  59. 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).

    Measured: 1 month

  60. 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).

    Measured: 3 months

  61. 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.

    Measured: Baseline (day 0)

  62. 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.

    Measured: On hospital discharge (expected maximum of 28 days)

  63. 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.

    Measured: 1 month

  64. 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.

    Measured: 3 months

  65. The modified medical research council (mMRC) dyspnoea scale

    Scores range from 0 (none) to 4 (very severe).

    Measured: Baseline (day 0)

  66. The modified medical research council (mMRC) dyspnoea scale

    Scores range from 0 (none) to 4 (very severe).

    Measured: 3 months

  67. The COPD assessment test

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: Baseline (day 0)

  68. The COPD assessment test

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: 1 month

  69. The COPD assessment test

    Scores range from 0-40 with higher scores indicative of greater COPD impact on health status.

    Measured: 3 months

  70. 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.

    Measured: Baseline (day 0)

  71. 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.

    Measured: 1 month

  72. 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.

    Measured: 3 months

  73. The St George Respiratory Questionnaire

    Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: 3 months

  74. Six minute walking tests

    Measured: 1 month (optional)

  75. Six minute walking tests

    Measured: 3 months

  76. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2020
  2. Study start12 Oct 2021
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Why it stopped: low enrollment at participating centers

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04234360
Sponsor's protocol ID
RECHMPL19_0069 UF 7771
Other IDs
2019-002724-33, LIC-18-18-0374, 2019
Acronym
eo-Drive
Status last verified
Jun 2026
First submitted
13 Jan 2020
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 32611741

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5 days of systemic corticotherapy (prednisone) in people with COPD Exacerbation, run by University Hospital, Montpellier at 18 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: low enrollment at participating centers). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment failure (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04234360, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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