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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01353235
Recruitment Status : Completed
First Posted : May 13, 2011
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
COPD Exacerbation Drug: Prednisolone Drug: usual care Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance
Study Start Date : April 2010
Primary Completion Date : June 2013
Study Completion Date : June 2013


Arms and Interventions

Arm Intervention/treatment
Sham Comparator: 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.


Outcome Measures

Primary Outcome Measures :
  1. ICU mortality rate [ Time Frame: ICU stay (on average patients will be followed 30 days) ]

Secondary Outcome Measures :
  1. Length of MV (and ventilatory free days) [ Time Frame: ICU stay (on average patients will be followed 30 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353235


Locations
Tunisia
CHU F.Bourguiba
Monastir, Tunisia, 5000
Sponsors and Collaborators
Fekri Abroug
Investigators
Principal Investigator: Fekri Abroug, MD CHU F.Bourguiba Monastir
More Information

Publications:
Responsible Party: Fekri Abroug, ead of the ICU, Hôpital Universitaire Fattouma Bourguiba
ClinicalTrials.gov Identifier: NCT01353235     History of Changes
Other Study ID Numbers: steroids in COPD exacerbation
First Posted: May 13, 2011    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to IPD so far

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

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