Oral or IV prednisolone in the treatment of COPD exacerbations - A randomized, controlled, double-blind study

Ynze P. de Jong; Steven M. Uil; Hans P. Grotjohan; Dirkje S. Postma; Huib A. M. Kerstjens; Jan W. K. van den Berg

doi:10.1378/chest.07-0208

Oral or IV prednisolone in the treatment of COPD exacerbations - A randomized, controlled, double-blind study

Ynze P. de Jong^*, Steven M. Uil, Hans P. Grotjohan, Dirkje S. Postma, Huib A. M. Kerstjens, Jan W. K. van den Berg

^*Corresponding author for this work

Groningen Research Institute for Asthma and COPD (GRIAC)

Research output: Contribution to journal › Article › Academic › peer-review

122 Citations (Scopus)

Abstract

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 IN 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 I 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.

Original language	English
Pages (from-to)	1741-1747
Number of pages	7
Journal	Chest
Volume	132
Issue number	6
DOIs	https://doi.org/10.1378/chest.07-0208
Publication status	Published - Dec-2007

Keywords

COPD
exacerbation
IV prednisolone
oral prednisolone
OBSTRUCTIVE PULMONARY-DISEASE
CONTROLLED CLINICAL-TRIAL
INTRAVENOUS CORTICOSTEROIDS
RESPIRATORY QUESTIONNAIRE
EMERGENCY TREATMENT
CHRONIC-BRONCHITIS
METHYLPREDNISOLONE
MANAGEMENT
STRATEGY
THERAPY

Access to Document

10.1378/chest.07-0208

Handle.net

Persistent link

Cite this

@article{3774fa0f33494ce2b891953b6ce2e41c,

title = "Oral or IV prednisolone in the treatment of COPD exacerbations - A randomized, controlled, double-blind study",

abstract = "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 IN 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 I 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.",

keywords = "COPD, exacerbation, IV prednisolone, oral prednisolone, OBSTRUCTIVE PULMONARY-DISEASE, CONTROLLED CLINICAL-TRIAL, INTRAVENOUS CORTICOSTEROIDS, RESPIRATORY QUESTIONNAIRE, EMERGENCY TREATMENT, CHRONIC-BRONCHITIS, METHYLPREDNISOLONE, MANAGEMENT, STRATEGY, THERAPY",

author = "{de Jong}, {Ynze P.} and Uil, {Steven M.} and Grotjohan, {Hans P.} and Postma, {Dirkje S.} and Kerstjens, {Huib A. M.} and {van den Berg}, {Jan W. K.}",

year = "2007",

month = dec,

doi = "10.1378/chest.07-0208",

language = "English",

volume = "132",

pages = "1741--1747",

journal = "Chest",

issn = "0012-3692",

publisher = "ELSEVIER SCIENCE BV",

number = "6",

}

TY - JOUR

T1 - Oral or IV prednisolone in the treatment of COPD exacerbations - A randomized, controlled, double-blind study

AU - de Jong, Ynze P.

AU - Uil, Steven M.

AU - Grotjohan, Hans P.

AU - Postma, Dirkje S.

AU - Kerstjens, Huib A. M.

AU - van den Berg, Jan W. K.

PY - 2007/12

Y1 - 2007/12

N2 - 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 IN 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 I 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.

AB - 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 IN 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 I 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.

KW - COPD

KW - exacerbation

KW - IV prednisolone

KW - oral prednisolone

KW - OBSTRUCTIVE PULMONARY-DISEASE

KW - CONTROLLED CLINICAL-TRIAL

KW - INTRAVENOUS CORTICOSTEROIDS

KW - RESPIRATORY QUESTIONNAIRE

KW - EMERGENCY TREATMENT

KW - CHRONIC-BRONCHITIS

KW - METHYLPREDNISOLONE

KW - MANAGEMENT

KW - STRATEGY

KW - THERAPY

U2 - 10.1378/chest.07-0208

DO - 10.1378/chest.07-0208

M3 - Article

SN - 0012-3692

VL - 132

SP - 1741

EP - 1747

JO - Chest

JF - Chest

IS - 6

ER -

Oral or IV prednisolone in the treatment of COPD exacerbations - A randomized, controlled, double-blind study

Abstract

Keywords

Access to Document

Handle.net

Fingerprint

Cite this