Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
|ClinicalTrials.gov Identifier: NCT01353235|
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : August 1, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD Exacerbation||Drug: Prednisolone Drug: usual care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||317 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
|Sham Comparator: usual care||
Drug: usual care
no drug administered
Active Comparator: Prednisolone
1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days
Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.
- ICU mortality rate [ Time Frame: ICU stay (on average patients will be followed 30 days) ]
- Length of MV (and ventilatory free days) [ Time Frame: ICU stay (on average patients will be followed 30 days) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353235
|Monastir, Tunisia, 5000|
|Principal Investigator:||Fekri Abroug, MD||CHU F.Bourguiba Monastir|