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

Last updated: July 31, 2017
Sponsor: Fekri Abroug
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT01353235
steroids in COPD exacerbation
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All COPD patients (according to the ATS definition) experiencing acute exacerbationoriginating in acute respiratory failure and requiring ICU admission will be includedin the study. COPD exacerbation is defined by the increased frequency of cough, volume and purulence ofsputum and that of wheeze. Acute respiratory failure is defined by the presence of hypercapnia with PaCO2 >45mmHgassociated with pH > 7.35 and signs of respiratory muscle fatigue (contraction of accessoryrespiratory muscles, thoracoabdominal swinging ,..).

Exclusion

Exclusion Criteria:

  • Asthmatic patients defined by a reversible obstructive disease following nebulizedbronchodilators,

  • 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, uncontrolledsepsis, etc. ..)

Study Design

Total Participants: 317
Study Start date:
April 01, 2010
Estimated Completion Date:
June 30, 2013

Connect with a study center

  • CHU F.Bourguiba

    Monastir, 5000
    Tunisia

    Site Not Available

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