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Sponsored by: |
Isala Klinieken |
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Information provided by: | Isala Klinieken |
ClinicalTrials.gov Identifier: | NCT00311961 |
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 |
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Chronic Obstructive Pulmonary Disease |
Drug: Intravenous prednisolone Drug: Oral prednisolone |
Phase IV |
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 |
Estimated Enrollment: | 256 |
Study Start Date: | June 2001 |
Estimated Study Completion Date: | August 2003 |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Netherlands, Overijssel | |
Isala Klinieken | |
Zwolle, Overijssel, Netherlands, 8000 GM |
Principal Investigator: | Jan WK van den Berg, MD, PhD | Isala Klinieken |
Principal Investigator: | Ynze P de Jong, MD | Isala Klinieken |
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) |
COPD Exacerbations Corticosteroids |
Oral Intravenous Chronic Obstructive Pulmonary Disease (COPD) |
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 |
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 |