Status:

COMPLETED

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

Lead Sponsor:

Isala

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

40+ years

Phase:

PHASE4

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. Up...

Eligibility Criteria

Inclusion

  • Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] severity stage II)
  • Smoking history of \> 10 pack years

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2001

Trial Type :

INTERVENTIONAL

End Date :

August 1 2003

Estimated Enrollment :

256 Patients enrolled

Trial Details

Trial ID

NCT00311961

Start Date

June 1 2001

End Date

August 1 2003

Last Update

August 26 2009

Active Locations (1)

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1

Isala Klinieken

Zwolle, Overijssel, Netherlands, 8000 GM