Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded. Randomization is stratified according to ventilatory support: non invasive or conventional ventilation.The major outcome is the ICU mortality rate in overall population and stratified according to ventilatory mode (noninvasive ventilation (NIV) versus conventional). Secondary outcomes are superinfection necessitating a new antibiotic course, Length of mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of gastric bleeding episodes that of frequency of hyperglycemic episodes.

Official Title
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A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance

Conditions
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COPD Exacerbation

Intervention / Treatment
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* Drug: Prednisolone
* Drug: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All COPD patients (according to the ATS definition) experiencing acute exacerbation originating in acute respiratory failure and requiring ICU admission will be included in the study. COPD exacerbation is defined by the increased frequency of cough, volume and purulence of sputum and that of wheeze. Acute respiratory failure is defined by the presence of hypercapnia with PaCO2 >45mmHg associated with pH > 7.35 and signs of respiratory muscle fatigue (contraction of accessory respiratory muscles, thoracoabdominal swinging ,..). Exclusion Criteria: Asthmatic patients defined by a reversible obstructive disease following nebulized bronchodilators, Patients with uncontrolled left heart failure, AECOPD patients with a radiologically documented pneumonia, Systemic corticotherapy within 30 days before screening, contra-indication to corticosteroids (active gastroduodenal ulcer, uncontrolled sepsis, etc. ..)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: usual care<br> | Drug: usual care<br>* no drug administered<br>|
| Active Comparator: Prednisolone<br>1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days | Drug: Prednisolone<br>* Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality rate |  | ICU stay (on average patients will be followed 30 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of MV (and ventilatory free days) |  | ICU stay (on average patients will be followed 30 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, acute respiratory failure, mechanical ventilation, non invasive ventilation, steroids