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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-06-30

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.

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Detailed Description

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Conditions

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COPD Exacerbation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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usual care

Group Type SHAM_COMPARATOR

usual care

Intervention Type DRUG

no drug administered

Prednisolone

1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.

Interventions

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Prednisolone

Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.

Intervention Type DRUG

usual care

no drug administered

Intervention Type DRUG

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. ..)

Eligible Sex

ALL

Accepts Healthy Volunteers

No