drugset / Trial / NCT00311961

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

NCT00311961 ↗

Phase 4 Completed 256 enrolled Isala
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2001-06
Primary completion
2003-08
Completion
2003-08

Outcome

Met primary endpoint

paper CONCLUSION: Therapy with oral prednisolone is not inferior to IV treatment in the first 90 days after starting therapy. PMID 17646228 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified 60 mg Intravenous