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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311961
• Other study ID #: IK-001
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2006
• Last updated: August 25, 2009
• Start date: June 2001
• Est. completion date: August 2003

Study information

• Verified date: August 2009
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Intravenous prednisolone

• Oral prednisolone

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Isala

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment failure defined as: death from any cause
Primary	admission to the intensive care unit
Primary	readmission to the hospital because of COPD
Primary	and the necessity to intensify pharmacologic treatment
Secondary	Changes in forced expiratory volume in 1 second (FEV1)
Secondary	St. George's Respiratory Questionnaire (SGRQ) scores
Secondary	Clinical COPD Questionnaire (CCQ) scores
Secondary	and length of hospital stay