Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by:
Isala Klinieken
ClinicalTrials.gov Identifier:
NCT00311961
First received: April 5, 2006
Last updated: August 25, 2009
Last verified: August 2009
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Intravenous prednisolone
Drug: Oral prednisolone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Isala Klinieken:

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

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

Estimated Enrollment: 256
Study Start Date: June 2001
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00311961

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

No publications provided by Isala Klinieken

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00311961     History of Changes
Other Study ID Numbers: IK-001
Study First Received: April 5, 2006
Last Updated: August 25, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:
COPD
Exacerbations
Corticosteroids
Oral
Intravenous
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
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 July 20, 2014