Back to resultsIntravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Intravenous prednisolone
Oral prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Exacerbations, Corticosteroids, Oral, Intravenous, Chronic Obstructive Pulmonary Disease (COPD)
Eligibility 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
Sites / Locations
- Isala Klinieken
Outcomes
Primary Outcome Measures
Treatment failure defined as: death from any cause
admission to the intensive care unit
readmission to the hospital because of COPD
and the necessity to intensify pharmacologic treatment
Secondary Outcome Measures
Changes in forced expiratory volume in 1 second (FEV1)
St. George's Respiratory Questionnaire (SGRQ) scores
Clinical COPD Questionnaire (CCQ) scores
and length of hospital stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311961
Brief Title
Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isala
4. Oversight
5. Study Description
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Exacerbations, Corticosteroids, Oral, Intravenous, Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
256 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Intravenous prednisolone
Intervention Type
Drug
Intervention Name(s)
Oral prednisolone
Primary Outcome Measure Information:
Title
Treatment failure defined as: death from any cause
Title
admission to the intensive care unit
Title
readmission to the hospital because of COPD
Title
and the necessity to intensify pharmacologic treatment
Secondary Outcome Measure Information:
Title
Changes in forced expiratory volume in 1 second (FEV1)
Title
St. George's Respiratory Questionnaire (SGRQ) scores
Title
Clinical COPD Questionnaire (CCQ) scores
Title
and length of hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan WK van den Berg, MD, PhD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ynze P de Jong, MD
Organizational Affiliation
Isala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
State/Province
Overijssel
ZIP/Postal Code
8000 GM
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
17646228
Citation
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.
Results Reference
derived
Learn more about this trial
Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
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