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

COPD Exacerbation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01353235
• Other study ID #: steroids in COPD exacerbation
• Status: Completed
• Phase: Phase 3
• First received: May 10, 2011
• Last updated: July 31, 2017
• Start date: April 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2017
• Source: Hôpital Universitaire Fattouma Bourguiba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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. ..)

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Prednisolone
Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.
• usual care
no drug administered

Locations

Country	Name	City	State
Tunisia	CHU F.Bourguiba	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
Fekri Abroug

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU mortality rate		ICU stay (on average patients will be followed 30 days)
Secondary	Length of MV (and ventilatory free days)		ICU stay (on average patients will be followed 30 days)