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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00632554
First Posted: March 10, 2008
Last Update Posted: September 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Naoki Inui, Hamamatsu University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Naoki Inui, Hamamatsu University:

Primary Outcome Measures:
  • Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: Three years ]

Secondary Outcome Measures:
  • Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: Three years ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Naoki Inui, Department of Respiratory Medicine, Hamamatsu University
ClinicalTrials.gov Identifier: NCT00632554     History of Changes
Other Study ID Numbers: Hamamatsu-18-67
First Submitted: February 28, 2008
First Posted: March 10, 2008
Last Update Posted: September 19, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Pneumonia
Chronic Disease
Pulmonary Eosinophilia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents