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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2003-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intravenous prednisolone

Intervention Type DRUG

Oral prednisolone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No