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| Sponsored by: |
Hamamatsu University |
|---|---|
| Information provided by: | Hamamatsu University |
| ClinicalTrials.gov Identifier: | NCT00632554 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 4, Randomized Study of Three Months-Prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia |
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
prednisolone therapy for three months
|
Drug: prednisolone 0.5 mg/kg/day for three months
period of treatment
|
|
2: Active Comparator
prednisolone therapy for six months
|
Drug: prednisolone 0.5 mg/kg/day for six months
period of therapy
|
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Naoki Inui, MD, PhD | 81-53-435-2385 | may15@hama-med.ac.jp |
| Japan | |
| Hamamatsu University School of Medicine | Recruiting |
| Hamamatsu, Japan | |
| Contact: Naoki Inui, MD, PhD 81-53-435-2385 may15@hama-med.ac.jp | |
| Study Chair: | Kingo Chida, MD, PhD | Hamamatsu University |
More Information
| Responsible Party: | Hamamatsu University School of Medicine, Respiratory Medicine ( Hamamatsu University School of Medicine, Respiratory Medicine ) |
| Study ID Numbers: | Hamamatsu-18-67 |
| Study First Received: | February 28, 2008 |
| Last Updated: | February 27, 2009 |
| ClinicalTrials.gov Identifier: | NCT00632554 History of Changes |
| Health Authority: | Japan: Institutional Review Board |
|
Anti-Inflammatory Agents Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Leukocyte Disorders Prednisolone acetate Neuroprotective Agents Hormones Respiratory Tract Infections Respiratory Tract Diseases Hypereosinophilic Syndrome Idiopathic Hypereosinophilic Syndrome |
Pulmonary Eosinophilia Pneumonia, Eosinophilic Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Hematologic Diseases Methylprednisolone acetate Eosinophilia Glucocorticoids Lung Diseases Prednisolone Chronic Disease Peripheral Nervous System Agents Pneumonia |
|
Anti-Inflammatory Agents Disease Attributes Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Leukocyte Disorders Prednisolone acetate Neuroprotective Agents Hormones Pathologic Processes Respiratory Tract Infections Respiratory Tract Diseases Hypereosinophilic Syndrome |
Therapeutic Uses Pulmonary Eosinophilia Methylprednisolone Hemisuccinate Antineoplastic Agents, Hormonal Hematologic Diseases Gastrointestinal Agents Methylprednisolone acetate Protective Agents Eosinophilia Glucocorticoids Pharmacologic Actions Autonomic Agents Lung Diseases Prednisolone Chronic Disease |
