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First published online on July 23, 2007
Chest, doi:10.1378/chest.07-0208
A more recent version of this article appeared on December 1, 2007
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Oral or Intravenous Prednisolone in the Treatment of COPD Exacerbations: a randomized controlled, double blind study

Ynze P de Jong, MD1; Steven M Uil, MSc1; Hans P Grotjohan, MD, PhD1; Dirkje S Postma, MD, PhD2; Huib AM Kerstjens, MD, PhD2 and Jan WK van den Berg, MD, PhD1

1Department of Pulmonology, Isala klinieken, Zwolle 2Department of Pulmonology, University Medical Center Groningen, Groningen

y.p.de.jong{at}isala.nl

Abstract

Background: Treatment with systemic corticosteroids for exacerbations of COPD results in improvement in clinical outcomes. Upon hospitalization, corticosteroids are generally administered intravenously. It has not been established whether oral administration is equally effective. We conducted a study to demonstrate the non-inferiority of oral as compared with intravenous prednisolone using a double-blind, double-dummy design.

Methods: Patients hospitalized for an exacerbation of COPD were randomized to 5 days of 60 mg prednisolone intravenously or orally. Treatment failure, the primary outcome, was defined as death, admission to ICU, readmission for COPD, or intensification of pharmacological therapy during a 90-day follow-up.

Results: 435 patients were referred for a COPD exacerbation warranting hospitalization; 107 patients were randomized to intravenous and 103 to oral therapy. Overall treatment failure within 90 days was similar: 61.7% on intravenous and 56.3% on oral prednisolone (one-sided 95% confidence lower bound of the difference -5.8%). There were also no differences in early (within 2 weeks) treatment failure (17.8% and 18.4%, respectively, one-sided 95% confidence lower bound -9.4%), late (after 2 weeks) treatment failure (54.0% and 47.0%, one-sided 95% confidence lower bound -5.6%), and length of hospital stay (11.9±8.6 and 11.2±6.7 days). Over 1 week clinically relevant improvements were found in spirometry and health related quality of life, without significant differences between the two treatment groups.

Conclusion: Oral prednisolone is not inferior to intravenous treatment in the first 90 days after starting therapy. We suggest that the oral route is preferable in the treatment of COPD exacerbations.

Trial registration: Clinicaltrials.gov Identifier: NCT00311961

Key Words: COPD • Exacerbation • Prednisolone • Oral • Intravenous


Related Editorial

Oral vs IV Corticosteroids for In-hospital Treatment of COPD Exacerbations
Donald P. Tashkin
Chest 2007 132: 1728-1729. [Full Text] [PDF]



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D. P. Tashkin
Oral vs IV Corticosteroids for In-hospital Treatment of COPD Exacerbations
Chest, December 1, 2007; 132(6): 1728 - 1729.
[Full Text] [PDF]




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