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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01353235

Enrollment

317

Registered

2011-05-13

Start date

2010-04-30

Completion date

2013-06-30

Last updated

2017-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

Keywords

COPD, acute respiratory failure, mechanical ventilation, non invasive ventilation, steroids

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.

Interventions

DRUGPrednisolone

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

DRUGusual care

no drug administered

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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. ..)

Design outcomes

Primary

Measure	Time frame
ICU mortality rate	ICU stay (on average patients will be followed 30 days)

Secondary

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

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026