Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Intravenous prednisolone (Drug); Oral prednisolone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Isala Klinieken

Official(s) and/or principal investigator(s):
Jan WK van den Berg, MD, PhD, Principal Investigator, Affiliation: Isala Klinieken
Ynze P de Jong, MD, Principal Investigator, Affiliation: Isala Klinieken

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.

Official title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-equivalence Study

Primary outcome:

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:

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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): 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

Isala Klinieken, Zwolle, Overijssel 8000 GM, Netherlands

Starting date: June 2001
Ending date: August 2003
Last updated: April 11, 2006