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

NCT00311961 | Completed Phase 4

• 1 other identifier: IK-001
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Exacerbations; Corticosteroids; Oral; Intravenous; Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Interventions

Intravenous prednisolone DRUG

Oral prednisolone DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exacerbation of COPD (at least Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] severity stage II)
• Smoking history of \> 10 pack years

You may not qualify if:

• 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

Sponsors & Collaborators

• Isala: lead

Study Sites (1)

Isala Klinieken

Zwolle, Overijssel, 8000 GM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 17646228 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jan WK van den Berg, MD, PhD

  Isala

  PRINCIPAL INVESTIGATOR

• Ynze P de Jong, MD

  Isala

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2006
• First Posted: April 7, 2006
• Study Start: June 1, 2001
• Primary Completion: August 1, 2003
• Study Completion: August 1, 2003
• Last Updated: August 26, 2009

Record last verified: 2009-08

Locations

NL (1)