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Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
First Received: April 5, 2006   Last Updated: April 11, 2006   History of Changes
Sponsored by: Isala Klinieken
Information provided by: Isala Klinieken
ClinicalTrials.gov Identifier: NCT00311961
  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 IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-equivalence Study
Official Title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease

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
Estimated Study Completion Date: August 2003
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311961

Locations
Netherlands, Overijssel
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 National Clinical Trials Identifier (NCT ID):
Study ID Numbers: IK-001
Study First Received: April 5, 2006
Last Updated: April 11, 2006
ClinicalTrials.gov Identifier: NCT00311961     History of Changes
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)

Study placed in the following topic categories:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Methylprednisolone
Hormone Antagonists
Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Methylprednisolone acetate
Prednisolone acetate
Neuroprotective Agents
Glucocorticoids
Hormones
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Prednisolone
Peripheral Nervous System Agents
Pulmonary Disease, Chronic Obstructive
Methylprednisolone Hemisuccinate

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

ClinicalTrials.gov processed this record on May 07, 2009