Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Information source: Hôpital Universitaire Fattouma Bourguiba
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: COPD Exacerbation
Intervention: Prednisolone (Drug); usual care (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Hôpital Universitaire Fattouma Bourguiba Official(s) and/or principal investigator(s):
Fekri Abroug, MD, Principal Investigator, Affiliation: CHU F.Bourguiba Monastir
Overall contact:
Fekri Abroug, MD, Phone: +21673460672, Email: f.abroug@rns.tn
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.
Clinical Details
Official title: A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: ICU mortality rate
Secondary outcome: Length of MV (and ventilatory free days)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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. ..)
Locations and Contacts
Fekri Abroug, MD, Phone: +21673460672, Email: f.abroug@rns.tn
CHU F.Bourguiba, Monastir 5000, Tunisia; Recruiting
Fekri Abroug, MD, Phone: +21673460672, Email: f.abroug@rns.tn
Lamia Besbes, MD, Sub-Investigator
Fahmi Dachraoui, MD, Sub-Investigator
Islem Ouanes, MD, Sub-Investigator
Additional Information
Related publications: Chang KC, Leung CC, Kong FY. Corticosteroid administration and treatment failure in acute exacerbation of chronic obstructive pulmonary disease. JAMA. 2010 Oct 13;304(14):1554; author reply 1554-6. doi: 10.1001/jama.2010.1438. Gunen H, Mirici A, Meral M, Akgün M. Steroids in acute exacerbations of chronic obstructive pulmonary disease: are nebulized and systemic forms comparable? Curr Opin Pulm Med. 2009 Mar;15(2):133-7. doi: 10.1097/MCP.0b013e32832185da. Review.
Starting date: April 2010
Last updated: May 12, 2011
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