Trial | NCT00311961  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    prednisone ...

  • Study Participants

    256
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.
Study Started
Jun 30
2001
Primary Completion
Aug 31
2003
Study Completion
Aug 31
2003
Last Update
Aug 26
2009
Estimate

Drug Intravenous prednisolone

Drug Oral prednisolone

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
No Results Posted