The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia - Full Text View

Sponsor:	Hamamatsu University
Information provided by (Responsible Party):	Naoki Inui, Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00632554

Purpose

A comparison of 3 months-prednisolone administration with 6 months-prednisolone therapy in the treatment of chronic eosinophilic pneumonia. Three months-prednisolone administration may be as effective as 6 months-therapy.

Condition	Intervention	Phase
Eosinophilic Pneumonia Chronic Disease	Drug: prednisolone 0.5 mg/kg/day for three months Drug: prednisolone 0.5 mg/kg/day for six months	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Coping with Chronic Illness Pneumonia

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 Hamamatsu University:

Primary Outcome Measures:

Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	June 2007
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 prednisolone therapy for three months	Drug: prednisolone 0.5 mg/kg/day for three months period of treatment Other Name: prednisolone
Active Comparator: 2 prednisolone therapy for six months	Drug: prednisolone 0.5 mg/kg/day for six months period of therapy Other Name: prednisolone

Eligibility

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

Patients who received oral glucocorticosteroid (more than 10 mg)
Immunosuppressive drug

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632554

Locations

Japan
Hamamatsu University School of Medicine
Hamamatsu, Japan

Sponsors and Collaborators

Hamamatsu University

Investigators

Study Chair:

Kingo Chida, MD, PhD

Hamamatsu University

More Information

No publications provided

Responsible Party:	Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
ClinicalTrials.gov Identifier:	NCT00632554 History of Changes
Other Study ID Numbers:	Hamamatsu-18-67
Study First Received:	February 28, 2008
Last Updated:	September 5, 2011
Health Authority:	Japan: Institutional Review Board

Additional relevant MeSH terms:

Chronic Disease
Pneumonia
Pulmonary Eosinophilia
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic 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

ClinicalTrials.gov processed this record on February 09, 2012