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

NCT01353235 | Completed Phase 3

• 1 other identifier: steroids in COPD exacerbation
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ICU mortality rate

  ICU stay (on average patients will be followed 30 days)

Secondary Outcomes (1)

• Length of MV (and ventilatory free days)

  ICU stay (on average patients will be followed 30 days)

Study Arms (2)

usual care

SHAM COMPARATOR

Drug: usual care

Prednisolone

ACTIVE COMPARATOR

1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days

Drug: Prednisolone

Interventions

Prednisolone DRUG

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

Prednisolone

usual care DRUG

no drug administered

usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ,..).

You may not qualify if:

• 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. ..)

Sponsors & Collaborators

• Fekri Abroug: lead

Study Sites (1)

CHU F.Bourguiba

Monastir, 5000, Tunisia

Location

Related 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. No abstract available.

  PMID: 20940378 BACKGROUND

• 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.

  PMID: 19532028 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Fekri Abroug, MD

  CHU F.Bourguiba Monastir

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ead of the ICU

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 13, 2011
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)