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OpenTrials
Completed

NCT Number: NCT00311961

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Isala Klinieken

Zwolle, Overijssel, 8000 GM, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous prednisolone

Drug

Oral prednisolone

Drug

Primary outcomes

  1. Treatment failure defined as: death from any cause

  2. admission to the intensive care unit

  3. readmission to the hospital because of COPD

  4. and the necessity to intensify pharmacologic treatment

Secondary outcomes

  1. Changes in forced expiratory volume in 1 second (FEV1)

  2. St. George's Respiratory Questionnaire (SGRQ) scores

  3. Clinical COPD Questionnaire (CCQ) scores

  4. and length of hospital stay

Sponsors and collaborators

Lead sponsor

Isala

Other

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Apr 7, 2006
Registry last updated
Aug 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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