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:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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
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 ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00311961 History of Changes
Other Study ID Numbers:	IK-001
Study First Received:	April 5, 2006
Last Updated:	August 25, 2009
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:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012