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

This study has been completed.
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University Identifier:
First received: February 28, 2008
Last updated: September 18, 2014
Last verified: September 2014
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 4

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:

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 2008
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


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

Inclusion Criteria:

  • Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

  • Patients who received oral glucocorticosteroid (more than 10 mg)
  • Immunosuppressive drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00632554

Hamamatsu University School of Medicine
Hamamatsu, Japan
Sponsors and Collaborators
Hamamatsu University
Study Chair: Kingo Chida, MD, PhD Hamamatsu University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Naoki Inui, Department of Respiratory Medicine, Hamamatsu University Identifier: NCT00632554     History of Changes
Other Study ID Numbers: Hamamatsu-18-67 
Study First Received: February 28, 2008
Last Updated: September 18, 2014
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Chronic Disease
Pulmonary Eosinophilia
Disease Attributes
Hematologic Diseases
Hypereosinophilic Syndrome
Leukocyte Disorders
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents processed this record on May 25, 2016