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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Hôpital Universitaire Fattouma Bourguiba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hôpital Universitaire Fattouma Bourguiba
ClinicalTrials.gov Identifier:
NCT01353235
First received: May 10, 2011
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
COPD Exacerbation
Drug: Prednisolone
Drug: usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance

Resource links provided by NLM:


Further study details as provided by Hôpital Universitaire Fattouma Bourguiba:

Primary Outcome Measures:
  • ICU mortality rate [ Time Frame: ICU stay (on average patients will be followed 30 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of MV (and ventilatory free days) [ Time Frame: ICU stay (on average patients will be followed 30 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2010
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: usual care
patients will receive usual care
Drug: usual care
no drug administered
Active Comparator: Prednisolone
1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. ..)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353235

Contacts
Contact: Fekri Abroug, MD +21673460672 f.abroug@rns.tn

Locations
Tunisia
CHU F.Bourguiba Recruiting
Monastir, Tunisia, 5000
Contact: Fekri Abroug, MD    +21673460672    f.abroug@rns.tn   
Sub-Investigator: Lamia Besbes, MD         
Sub-Investigator: Fahmi Dachraoui, MD         
Sub-Investigator: Islem Ouanes, MD         
Sponsors and Collaborators
Hôpital Universitaire Fattouma Bourguiba
Investigators
Principal Investigator: Fekri Abroug, MD CHU F.Bourguiba Monastir
  More Information

Publications:
Responsible Party: Health Ministery, CHU F.Bourguiba Monastir
ClinicalTrials.gov Identifier: NCT01353235     History of Changes
Other Study ID Numbers: steroids in COPD exacerbation
Study First Received: May 10, 2011
Last Updated: May 12, 2011
Health Authority: Tunisia: Public Health Ministery

Keywords provided by Hôpital Universitaire Fattouma Bourguiba:
COPD
acute respiratory failure
mechanical ventilation
non invasive ventilation
steroids

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014