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CompletedNCT00311961Updated Aug 26, 2009

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

A Phase 4 interventional study of Intravenous prednisolone and Oral prednisolone in Chronic Obstructive Pulmonary Disease, sponsored by Isala. Completed at 1 site in Netherlands. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2009-08-26.

Sponsored by Isala · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
256
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • Exacerbations
  • Corticosteroids
  • Oral
  • Intravenous
  • Chronic Obstructive Pulmonary Disease (COPD)
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In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 256 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Isala is the lead sponsor of 36 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
256 participants

Interventions

  • DrugIntravenous prednisolone
  • DrugOral prednisolone
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What researchers measure

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

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Study locations

1 site
  • Isala Klinieken
    Zwolle, Overijssel 8000 GM, Netherlands
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References and documents

Publications

  • de Jong YP, Uil SM, Grotjohan HP, Postma DS, Kerstjens HA, van den Berg JW. Oral or IV prednisolone in the treatment of COPD exacerbations: a randomized, controlled, double-blind study. Chest. 2007 Dec;132(6):1741-7. doi: 10.1378/chest.07-0208. Epub 2007 Jul 23. PubMed 17646228 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00311961
Lead sponsor
Isala
First posted
Apr 7, 2006
Start date
Jun 2001
Primary completion
Aug 2003
Completion
Aug 2003
Last update
Aug 26, 2009

Study contacts

Jan WK van den Berg, MD, PhD
principal investigator · Isala
Ynze P de Jong, MD
principal investigator · Isala
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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