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

September 18, 2014 updated by: Naoki Inui, Hamamatsu University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hamamatsu, Japan
        • Hamamatsu University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
prednisolone therapy for three months
Drug: prednisolone 0.5 mg/kg/day for three months
period of treatment
Other Names:
  • prednisolone
Active Comparator: 2
prednisolone therapy for six months
Drug: prednisolone 0.5 mg/kg/day for six months
period of therapy
Other Names:
  • prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Time Frame: Three years
Three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Time Frame: Three years
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamamatsu University

Investigators

  • Study Chair: Kingo Chida, MD, PhD, Hamamatsu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 28, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamamatsu-18-67

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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