Clinical trial NCT01353235: Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COPD Exacerbation
Keywords: COPD
acute respiratory failure
mechanical ventilation
non invasive ventilation
steroids
Lead sponsor: Hôpital Universitaire Fattouma Bourguiba
Sponsor class: OTHER
First posted: 2011-05-13
Enrollment: 317
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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. ..)

Primary outcomes:
measure: ICU mortality rate
timeFrame: ICU stay (on average patients will be followed 30 days)
Secondary outcomes:
measure: Length of MV (and ventilatory free days)
timeFrame: ICU stay (on average patients will be followed 30 days)
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: CHU F.Bourguiba
Study officials:
affiliation: CHU F.Bourguiba Monastir
name: Fekri Abroug, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. No abstract available.
citation: Gunen H, Mirici A, Meral M, Akgun 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.