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

Sponsor:	Hamamatsu University
Information provided by:	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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: Naoki Inui, MD, PhD

81-53-435-2385

may15@hama-med.ac.jp

Locations

Japan
Hamamatsu University School of Medicine	Recruiting
Hamamatsu, Japan
Contact: Naoki Inui, MD, PhD 81-53-435-2385 may15@hama-med.ac.jp

Sponsors and Collaborators

Hamamatsu University

Investigators

Study Chair:

Kingo Chida, MD, PhD

Hamamatsu University

More Information

No publications provided

Responsible Party:	Hamamatsu University School of Medicine, Respiratory Medicine ( Hamamatsu University School of Medicine, Respiratory Medicine )
Study ID Numbers:	Hamamatsu-18-67
Study First Received:	February 28, 2008
Last Updated:	February 27, 2009
ClinicalTrials.gov Identifier:	NCT00632554 History of Changes
Health Authority:	Japan: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease Attributes
Antineoplastic Agents
Methylprednisolone
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Leukocyte Disorders
Prednisolone acetate
Neuroprotective Agents
Hormones
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Hypereosinophilic Syndrome

Therapeutic Uses
Pulmonary Eosinophilia
Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Hematologic Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Protective Agents
Eosinophilia
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Prednisolone
Chronic Disease

ClinicalTrials.gov processed this record on November 25, 2009