Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
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.
Status | Completed |
Enrollment | 256 |
Est. completion date | August 2003 |
Est. primary completion date | August 2003 |
Accepts healthy volunteers | |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Isala Klinieken | Zwolle | Overijssel |
Lead Sponsor | Collaborator |
---|---|
Isala |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment failure defined as: death from any cause | |||
Primary | admission to the intensive care unit | |||
Primary | readmission to the hospital because of COPD | |||
Primary | and the necessity to intensify pharmacologic treatment | |||
Secondary | Changes in forced expiratory volume in 1 second (FEV1) | |||
Secondary | St. George's Respiratory Questionnaire (SGRQ) scores | |||
Secondary | Clinical COPD Questionnaire (CCQ) scores | |||
Secondary | and length of hospital stay |
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