Chest
Volume 132, Issue 6, December 2007, Pages 1741-1747
Journal home page for Chest

Original Research
COPD
Oral or IV Prednisolone in the Treatment of COPD Exacerbations

https://doi.org/10.1378/chest.07-0208Get rights and content

Background

Treatment with systemic corticosteroids for exacerbations of COPD results in improvement in clinical outcomes. On hospitalization, corticosteroids are generally administered IV. It has not been established whether oral administration is equally effective. We conducted a study to demonstrate that therapy with oral prednisolone was not inferior to therapy with IV prednisolone using a double-blind, double-dummy design.

Methods

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

Results

A total of 435 patients were referred for a COPD exacerbation warranting hospitalization; 107 patients were randomized to receive IV therapy, and 103 to receive oral therapy. Overall treatment failure within 90 days was similar, as follows: IV prednisolone, 61.7%; oral prednisolone, 56.3% (one-sided lower bound of the 95% confidence interval [CI], −5.8%). There were also no differences in early (ie, within 2 weeks) treatment failure (17.8% and 18.4%, respectively; one-sided lower bound of the 95% CI, −9.4%), late (ie, after 2 weeks) treatment failure (54.0% and 47.0%, respectively; one-sided lower bound of the 95% CI, −5.6%), and mean (± SD) length of hospital stay (11.9 ± 8.6 and 11.2 ± 6.7 days, respectively). 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

Therapy with oral prednisolone is not inferior to IV 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.

Section snippets

Patients

Patients referred to the Isala klinieken hospital for an exacerbation of COPD were enrolled in the study from June 2001 to June 2003. Inclusion criteria were an age of > 40 years, a history of at least 10 pack-years of cigarette smoking, and evidence of airflow limitation. Airflow limitation was defined as an FEV1/FVC ratio of < 70% and an FEV1 of < 80% predicted (at least Global Initiative for Chronic Obstructive Lung Disease [GOLD] severity stage II).1617 An exacerbation of COPD was defined

Study Population

A total of 435 individuals with a total of 581 exacerbation episodes were referred to the Isala klinieken for an exacerbation of COPD. A total of 210 patients were eligible, of whom 107 were randomized to receive IV prednisolone, and 103 to receive oral prednisolone. Six patients withdrew consent before day 4 of the study, two patients in the IV prednisolone group and four patients in the oral prednisolone group. Another 11 patients were excluded from the per-protocol analysis because they did

Discussion

The administration of systemic corticosteroids for treatment of exacerbations of COPD was already widespread long before good evidence for its use became available in 1999.56 At least 10 studies567891011121314 have now studied the effects of systemic steroids in the treatment of exacerbations of COPD, but these studies varied considerably in terms of corticosteroid dosage, length of treatment, and route of administration. Customs vary considerably between and within countries. The GOLD,16 the

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