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

Phase 3

Completed

• Conditions: COPD Exacerbation
• Interventions: Drug: usual care; Drug: Prednisolone

• Registration Number: NCT01353235
• Lead Sponsor: Fekri Abroug

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-12
• Study First Posted: 2011-05-13
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-31
• Last Update Posted: 2017-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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. ..)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	usual care	-
Prednisolone	Prednisolone	1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days

Primary Outcome Measures

Name	Time	Method
ICU mortality rate	ICU stay (on average patients will be followed 30 days)

Secondary Outcome Measures

Name	Time	Method
Length of MV (and ventilatory free days)	ICU stay (on average patients will be followed 30 days)

Trial Locations

Locations (1)

CHU F.Bourguiba; 🇹🇳 Monastir, Tunisia