Copd Exacerbation AcutePhase 4EoPred-ICUNCT03981081
Prednisone Reduction in ICU Patients With COPD Exacerbation
A Phase 4 study testing Prednisone in people with Copd Exacerbation Acute and Mechanical Ventilation, run by Hôpital Universitaire Fattouma Bourguiba at 4 sites in 2 countries.
Trial summary
The aim of this multicenter, investigator-initiated, prospective, randomized, open-label, non-inferiority study is to evaluate a prednisone prescribing strategy, guided by eosinophil blood count compared to the standard (systematic) administration of corticosteroids, in patients with COPD exacerbation requiring… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd Exacerbation Acute, Mechanical Ventilation
- What is being tested?
- Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 2 Apr 2019to 1 Apr 2020
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with known or suspected COPD, and severe acute exacerbation of COPD, corresponding to an acute episode of exacerbation, associated with a hypercapnic respiratory failure (defined by RR> 25 cycles/min, Paco2> 6 kPa, and ph<7.35) requiring ICU admission for ventilatory support.
Who cannot join
- self-reported or physician-diagnosed asthma,
- life expectancy of less than 30 days,
- allergy to systemic corticosteroids,
- severe mental illness that could not be controlled by medication,
- severe language difficulties or the inability to provide a written informed consent,
- pneumonia or patent infection,
- systemic fungal infections, or
- patients receiving more than 10 mg of chronic systemic corticosteroids (prednisone equivalent) daily.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Morocco2 sites
- Active, not recruiting
CHU Arrazi
Marrakesh
- Active, not recruiting
CHU Ibn Cina
Rabat
Tunisia2 sites, 2 recruiting
- Recruiting
CHU Tahar Sfar
Mahdia, 5100
Souheil Elatrous, Prof, +21698403013, souheil.elatrous@rns.tn
- Recruiting
CHU Fattouma Bourguiba
Monastir, 5000
Lamia Ouanes-Besbes, Prof, +21673106013, lamia.besbes@rns.tn
Fekri Abroug, Prof, +21673460672, fekri.abroug@gmail.com
About this study
Official title: Eosinophil-guided Prednisone Administration in COPD Exacerbation Requiring Ventilatory Support
The aim of this multicenter, investigator-initiated, prospective, randomized, open-label, non-inferiority study is to evaluate a prednisone prescribing strategy, guided by eosinophil blood count compared to the standard (systematic) administration of corticosteroids, in patients with COPD exacerbation requiring ventilatory support.
Patients fulfilling inclusion criteria and consenting to participate in the study, will be randomized through a random table generated electronically, to eosinophil-guided group or to control group.
Read more
In the eosinophil-guided group, prednisone (1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days) is administered only if the eosinophil count is >2%. If blood eosinophil count is ≤2%, no corticosteroids are given. In the control group: a treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients.
The hypothesis tested is a non-inferiority of the "eosinophil-guided strategy" compared to the standard strategy, with less exposure to corticosteroids.
The primary endpoint is the proportion of unventilated patients at day 6 which is set to 50% in the control group. A pre-specified difference <10% would be a non-inferiority margin.
Secondary endpoints are: Number of ICU days alive without ventilatory support within 28 days after recruitment, length of stay in intensive care Unit, the intubation rate in patients initially under NIV, Mortality in the ICU, Hospital mortality.
Safety: New onset of diabetes or worsening of diabetes requiring the start or the increase in insulin therapy, Upper gastrointestinal bleeding (2 g drop of Hb requiring blood transfusion or fibroscopy), Uncontrolled hypertensive crisis requiring the introduction of new antihypertensives, ICU-acquired neuromyopathy, Nosocomial infection, Relapse rate / recurrence defined respectively by the rate of a new hospital consultation and/or admission in the week or the month following index hospitalization.
Sample size calculation: In a non-inferiority study, with an incidence of the event (no ventilation at D6) of 50% in the control group ( with 10% of acceptable difference for non-inferiority), a power of 80% and alpha error <0.05, it would take 86 patients per arm by anticipating 2% of lost sight.
Read the detailed description
The aim of this multicenter, investigator-initiated, prospective, randomized, open-label, non-inferiority study is to evaluate a prednisone prescribing strategy guided by eosinophil blood count compared to the standard (systematic) administration of corticosteroids in patients with COPD exacerbation requiring ventilatory support,.
Consecutive patients admitted to the ICU with hypercapnic respiratory failure consecutive to COPD exacerbation, and requiring ventilatory support with non-invasive or invasive mechanical ventilation, will be considered for inclusion in the study.
Patients fulfilling inclusion criteria and consenting to participate in the study, will be randomized through a random table generated electronically, to eosinophil-guided group or to control group.
In eosinophil-guided group, patients will receive prednisone at a dose of 1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days, only if the eosinophil count is> 2%,. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients.If blood eosinophil count is ≤2%, no corticosteroids are given.
In the control group: A treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients.
The associated medications will be administered in a standardized way The hypothesis tested is a non-inferiority of the "eosinophil-guided strategy" compared to the standard strategy, with less exposure to corticosteroids.
The primary endpoint is the proportion of unventilated patients at day 6 in study-groups which is set to 50% in the control group. A pre-specified difference <10% would be a non-inferiority margin.
Secondary endpoints are: Number of ICU days alive without ventilatory support within 28 days after recruitment, length of stay in intensive care Unit, the intubation rate in patients initially under NIV, Mortality in the ICU, Hospital mortality.
Safety:New onset of diabetes or worsening of diabetes requiring the start or the increase in insulin therapy, Upper gastrointestinal bleeding (2 g drop of Hb requiring blood transfusion or fibroscopy), Uncontrolled hypertensive crisis requiring the introduction of new antihypertensives, ICU-acquired neuromyopathy, Nosocomial infection, Relapse rate / recurrence defined respectively by the rate of a new hospital consultation and/or admission in the week or the month following index hospitalization.
Sample size calculation: In a non-inferiority study, with an incidence of the event (no ventilation at D6) of 50% in the standard group and this same incidence less than 60% (10% of acceptable difference for non-inferiority) , a power of 80% and alpha error <0.05, it would take 86 patients per arm by anticipating 2% of lost sight (http://www.pharmaschool.co/size8.asp).
- Conditions
- Copd Exacerbation Acute, Mechanical Ventilation
- Being tested
- Prednisone
- Keywords
- COPD, Acute hypercapnic respiratory failure, Steroids
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients
| Study group | Role | What they receive |
|---|---|---|
| eosinophil-guided group | Experimental | patients will receive prednisone at a dose of 1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days, only if the eosinophil count is> 2% Receives: Drug: Prednisone |
| control group | Active comparator | a treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of unventilated patients at day 6
patients breathing spontaneously by the 6th day following inclusion
Measured: day 6
Secondary outcomes (3)
Number of ICU days alive without ventilatory support within 28 days after recruitment
number of days without MV by the 28th day
Measured: up to 28 days
intubation rate in patients initially under NIV
NIV failure
Measured: up to 28 days
hospital death
death during hospitalisation
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start2 Apr 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Copd Exacerbation AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, randomized, open-label, parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Fattouma Bourguiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fekri Abroug, Hôpital Universitaire Fattouma Bourguiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981081
- Sponsor's protocol ID
- P01RM2019
- Acronym
- EoPred-ICU
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eosinophil-guided Prednisone Administration in COPD Exacerbation Requiring Ventilatory Support
- ClinicalTrials.gov ID
- NCT03981081
- Acronym / sponsor ID
- EoPred-ICU / P01RM2019
- Conditions
- Copd Exacerbation Acute, Mechanical Ventilation
- Keywords
- COPD, Acute hypercapnic respiratory failure, Steroids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hôpital Universitaire Fattouma BourguibaUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this multicenter, investigator-initiated, prospective, randomized, open-label, non-inferiority study is to evaluate a prednisone prescribing strategy, guided by eosinophil blood count compared to the standard (systematic) administration of corticosteroids, in patients with COPD exacerbation requiring ventilatory support.
Patients fulfilling inclusion criteria and consenting to participate in the study, will be randomized through a random table generated electronically, to eosinophil-guided group or to control group.
In the eosinophil-guided group, prednisone (1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days) is administered only if the eosinophil count is >2%. If blood eosinophil count is ≤2%, no corticosteroids are given. In the control group: a treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients.
The hypothesis tested is a non-inferiority of the "eosinophil-guided strategy" compared to the standard strategy, with less exposure to corticosteroids.
The primary endpoint is the proportion of unventilated patients at day 6 which is set to 50% in the control group. A pre-specified difference <10% would be a non-inferiority margin.
Secondary endpoints are: Number of ICU days alive without ventilatory support within 28 days after recruitment, length of stay in intensive care Unit, the intubation rate in patients initially under NIV, Mortality in the ICU, Hospital mortality.
Safety: New onset of diabetes or worsening of diabetes requiring the start or the increase in insulin therapy, Upper gastrointestinal bleeding (2 g drop of Hb requiring blood transfusion or fibroscopy), Uncontrolled hypertensive crisis requiring the introduction of new antihypertensives, ICU-acquired neuromyopathy, Nosocomial infection, Relapse rate / recurrence defined respectively by the rate of a new hospital consultation and/or admission in the week or the month following index hospitalization.
Sample size calculation: In a non-inferiority study, with an incidence of the event (no ventilation at D6) of 50% in the control group ( with 10% of acceptable difference for non-inferiority), a power of 80% and alpha error <0.05, it would take 86 patients per arm by anticipating 2% of lost sight.
Detailed description
The aim of this multicenter, investigator-initiated, prospective, randomized, open-label, non-inferiority study is to evaluate a prednisone prescribing strategy guided by eosinophil blood count compared to the standard (systematic) administration of corticosteroids in patients with COPD exacerbation requiring ventilatory support,.
Consecutive patients admitted to the ICU with hypercapnic respiratory failure consecutive to COPD exacerbation, and requiring ventilatory support with non-invasive or invasive mechanical ventilation, will be considered for inclusion in the study.
Patients fulfilling inclusion criteria and consenting to participate in the study, will be randomized through a random table generated electronically, to eosinophil-guided group or to control group.
In eosinophil-guided group, patients will receive prednisone at a dose of 1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days, only if the eosinophil count is> 2%,. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients.If blood eosinophil count is ≤2%, no corticosteroids are given.
In the control group: A treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days. Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients.
The associated medications will be administered in a standardized way The hypothesis tested is a non-inferiority of the "eosinophil-guided strategy" compared to the standard strategy, with less exposure to corticosteroids.
The primary endpoint is the proportion of unventilated patients at day 6 in study-groups which is set to 50% in the control group. A pre-specified difference <10% would be a non-inferiority margin.
Secondary endpoints are: Number of ICU days alive without ventilatory support within 28 days after recruitment, length of stay in intensive care Unit, the intubation rate in patients initially under NIV, Mortality in the ICU, Hospital mortality.
Safety:New onset of diabetes or worsening of diabetes requiring the start or the increase in insulin therapy, Upper gastrointestinal bleeding (2 g drop of Hb requiring blood transfusion or fibroscopy), Uncontrolled hypertensive crisis requiring the introduction of new antihypertensives, ICU-acquired neuromyopathy, Nosocomial infection, Relapse rate / recurrence defined respectively by the rate of a new hospital consultation and/or admission in the week or the month following index hospitalization.
Sample size calculation: In a non-inferiority study, with an incidence of the event (no ventilation at D6) of 50% in the standard group and this same incidence less than 60% (10% of acceptable difference for non-inferiority) , a power of 80% and alpha error <0.05, it would take 86 patients per arm by anticipating 2% of lost sight (http://www.pharmaschool.co/size8.asp).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multicenter, randomized, open-label, parallel groups
| Arm | Type | Receives |
|---|---|---|
| eosinophil-guided group | Experimental | Drug: Prednisonepatients will receive prednisone at a dose of 1mg/kg/day for up to 5 days or during the hospital stay if less than 5 days, only if the eosinophil count is> 2% |
| control group | Active comparator | Drug: Prednisonea treatment based on prednisone at a daily dose of 1 mg/kg will be routinely administered for a maximum of 5 days, or during the hospital stay, if it is less than 5 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with known or suspected COPD, and severe acute exacerbation of COPD, corresponding to an acute episode of exacerbation, associated with a hypercapnic respiratory failure (defined by RR> 25 cycles/min, Paco2> 6 kPa, and ph<7.35) requiring ICU admission for ventilatory support.
Key exclusion criteria (8 listed)
- self-reported or physician-diagnosed asthma,
- life expectancy of less than 30 days,
- allergy to systemic corticosteroids,
- severe mental illness that could not be controlled by medication,
- severe language difficulties or the inability to provide a written informed consent,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneCorticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients | Drug | control group, eosinophil-guided group |
Primary outcome
proportion of unventilated patients at day 6
Time frame: day 6
patients breathing spontaneously by the 6th day following inclusion
3 secondary outcomes
Number of ICU days alive without ventilatory support within 28 days after recruitment
Time frame: up to 28 days
intubation rate in patients initially under NIV
Time frame: up to 28 days
hospital death
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Copd Exacerbation Acute and Mechanical Ventilation, run by Hôpital Universitaire Fattouma Bourguiba at 4 sites in 2 countries.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Morocco, Tunisia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of unventilated patients at day 6 (time frame: day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2019.