Intravenous Versus Oral Administration of Prednisolone in Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsor:	Isala Klinieken
Information provided by:	Isala Klinieken
ClinicalTrials.gov Identifier:	NCT00311961

Purpose

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	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Intravenous prednisolone Drug: Oral prednisolone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-equivalence Study
Official Title:	A Comparison of Intravenous Versus Oral Administration of Prednisolone in the Treatment of Exacerbations of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone

U.S. FDA Resources

Further study details as provided by Isala Klinieken:

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

Estimated Enrollment:	256
Study Start Date:	June 2001
Study Completion Date:	August 2003
Primary Completion Date:	August 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311961

Locations

Netherlands, Overijssel
Isala Klinieken
Zwolle, Overijssel, Netherlands, 8000 GM

Sponsors and Collaborators

Isala Klinieken

Investigators

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

More Information

No publications provided by Isala Klinieken

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2007 Jul 23.

Study ID Numbers:	IK-001
Study First Received:	April 5, 2006
Last Updated:	August 25, 2009
ClinicalTrials.gov Identifier:	NCT00311961 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Isala Klinieken:

COPD
Exacerbations
Corticosteroids

Oral
Intravenous
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Methylprednisolone Hemisuccinate

Antineoplastic Agents, Hormonal
Respiration Disorders
Gastrointestinal Agents
Methylprednisolone acetate
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Prednisolone
Peripheral Nervous System Agents
Central Nervous System Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010