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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00311961
• Lead Sponsor: Isala

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-06
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2006-04-05
• Study First Submitted QC: 2006-04-05
• Study First Posted: 2006-04-07
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-25
• Last Update Posted: 2009-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Isala Klinieken; 🇳🇱 Zwolle, Overijssel, Netherlands