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

Isala

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Oral prednisolone; Drug: Intravenous prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT00311961

IK-001

Details and patient eligibility

About

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.

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind