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

• Sponsor: Isala (Other)
• Overall Status: Completed
• CT.gov ID: NCT00311961
• Collaborator: (none)
• Enrollment: 256
• Location: 1
• Duration (Months): 26
• Patients Per Site Per Month: 9.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Intravenous prednisolone; Drug: Oral prednisolone	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease
• Study Start Date: Jun 1, 2001
• Actual Primary Completion Date: Aug 1, 2003
• Actual Study Completion Date: Aug 1, 2003

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Isala Klinieken	Zwolle	Overijssel	Netherlands	8000 GM

Sponsors and Collaborators

• Isala

Investigators

• Principal Investigator: Jan WK van den Berg, MD, PhD, Isala
• Principal Investigator: Ynze P de Jong, MD, Isala

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00311961
• Other Study ID Numbers: IK-001
• First Posted: Apr 7, 2006
• Last Update Posted: Aug 26, 2009
• Last Verified: Aug 1, 2009

• Keywords provided by , ,: COPD; Exacerbations; Corticosteroids; Oral; Intravenous; Chronic Obstructive Pulmonary Disease (COPD)
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

No Results Posted as of Aug 26, 2009