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NCT00632554 Clinical Trial

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

Chronic Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00632554
Other study ID # Hamamatsu-18-67
Secondary ID
Status Completed
Phase Phase 4
First received February 28, 2008
Last updated September 18, 2014
Start date June 2008
Est. completion date March 2010

Study information
Verified date September 2014
Source Hamamatsu University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility Inclusion Criteria:

- Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

- Patients who received oral glucocorticosteroid (more than 10 mg)

- Immunosuppressive drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Japan Hamamatsu University School of Medicine Hamamatsu

Sponsors (1)
Lead Sponsor Collaborator
Hamamatsu University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia Three years Yes
Secondary Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia Three years Yes
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