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Intravenous Versus Oral Administration of Prednisolone in Exacerbations 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. Identifier: NCT00311961
Recruitment Status : Completed
First Posted : April 7, 2006
Last Update Posted : August 26, 2009
Information provided by:

Brief Summary:

Treatment with systemic corticosteroids for acute exacerbations of COPD results in the improvement of clinical outcomes. The optimal route of administration has not been rigorously studied in COPD. Upon hospitalization, corticosteroids are administered intravenously in many hospitals. Oral administration is more convenient, though, because there is no need for intravenous access, less personnel is required for starting and monitoring therapy, and material costs are smaller.

The investigators hypothesized that oral administration is not inferior to intravenous administration of prednisolone in the treatment of patients hospitalized for an acute exacerbation of COPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Intravenous prednisolone Drug: Oral prednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
Study Start Date : June 2001
Actual Primary Completion Date : August 2003
Actual Study Completion Date : August 2003

Primary Outcome Measures :
  1. Treatment failure defined as: death from any cause
  2. admission to the intensive care unit
  3. readmission to the hospital because of COPD
  4. and the necessity to intensify pharmacologic treatment

Secondary Outcome Measures :
  1. Changes in forced expiratory volume in 1 second (FEV1)
  2. St. George's Respiratory Questionnaire (SGRQ) scores
  3. Clinical COPD Questionnaire (CCQ) scores
  4. and length of hospital stay

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease [GOLD] severity stage II)
  • Smoking history of > 10 pack years

Exclusion Criteria:

  • Signs of severe exacerbation (arterial pH < 7.26 or pCO2 > 9.3 kPa)
  • History of asthma
  • Significant or unstable co-morbidity
  • Participated in another study 4 weeks before admission
  • Previously randomized to this study
  • Findings on chest radiography other than those fitting with signs of COPD
  • Known hypersensitivity to prednisolone
  • Non-compliant

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 identifier (NCT number): NCT00311961

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Isala Klinieken
Zwolle, Overijssel, Netherlands, 8000 GM
Sponsors and Collaborators
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Principal Investigator: Jan WK van den Berg, MD, PhD Isala
Principal Investigator: Ynze P de Jong, MD Isala

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00311961     History of Changes
Other Study ID Numbers: IK-001
First Posted: April 7, 2006    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Isala:
Chronic Obstructive Pulmonary Disease (COPD)

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