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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
ClinicalTrials.gov Identifier:
NCT00632554
First received: February 28, 2008
Last updated: September 5, 2011
Last verified: May 2010
History of Changes
  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 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:

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 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

ClinicalTrials.gov processed this record on May 16, 2013