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...
Date First Received: February 28, 2008
Last Updated: February 27, 2009
Verified by: Hamamatsu University, February 2009
Clinical Trial Phase: Phase 4 | Start Date: June 2007
Overall Status: Recruiting
Estimated Enrollment: 50
Brief Summary
Official Title: “Phase 4, Randomized Study of Three Months-Prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia”
Condition Keyword(s):
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: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
- Time Frame: Three years
Secondary Measures
- Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
- Time Frame: Three years
Safety Issue?: Yes
- Time Frame: Three years
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 Sponsor Information
Lead Sponsor: Hamamatsu University
Overall Clinical Trial Officials and Contacts
Kingo Chida, MD, PhD Study Chair Hamamatsu University
Overall Contact: Naoki Inui, MD, PhD 81-53-435-2385 may15@hama-med.ac.jp
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials Authorship and Review
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