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

Verified by: Hamamatsu University, May 2010
First Received: February 28, 2008 | Last Updated: September 5, 2011 | Phase: Phase 4 | Start Date: June 2007
Overall Status: Completed | Estimated Enrollment: 50
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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...

Brief Summary

Official Title: “Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2010

Intervention(s) in this Clinical Trial

  • Drug: prednisolone 0.5 mg/kg/day for three months
    • period of treatment
  • Drug: prednisolone 0.5 mg/kg/day for six months
    • period of therapy

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • prednisolone therapy for three months
  • Active Comparator: 2
    • prednisolone therapy for six months

Outcome Measures for this Clinical Trial

Primary Measures

  • Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
    • Time Frame: Three years
      Safety Issue?: Yes

Secondary Measures

  • Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
    • Time Frame: Three years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Hamamatsu University Other

Overall Clinical Trial Officials and Contacts

Kingo Chida, MD, PhD Study Chair Hamamatsu University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00632554

Study ID Number: Hamamatsu-18-67

ClinicalTrials.gov Identifier: NCT00632554

Health Authority: Japan: Institutional Review Board

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