search
Back to results

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

Primary Purpose

Eosinophilic Pneumonia, Chronic Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
prednisolone 0.5 mg/kg/day for three months
prednisolone 0.5 mg/kg/day for six months
Sponsored by
Hamamatsu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eosinophilic Pneumonia

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

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

Sites / Locations

  • Hamamatsu University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

prednisolone therapy for three months

prednisolone therapy for six months

Outcomes

Primary Outcome Measures

Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia

Secondary Outcome Measures

Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia

Full Information

First Posted
February 28, 2008
Last Updated
September 18, 2014
Sponsor
Hamamatsu University
search

1. Study Identification

Unique Protocol Identification Number
NCT00632554
Brief Title
The Efficacy of Three Months-prednisolone Therapy for Chronic Eosinophilic Pneumonia
Official Title
Phase 4, Randomized Study of Three Months-prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamamatsu University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eosinophilic Pneumonia, Chronic Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
prednisolone therapy for three months
Arm Title
2
Arm Type
Active Comparator
Arm Description
prednisolone therapy for six months
Intervention Type
Drug
Intervention Name(s)
prednisolone 0.5 mg/kg/day for three months
Other Intervention Name(s)
prednisolone
Intervention Description
period of treatment
Intervention Type
Drug
Intervention Name(s)
prednisolone 0.5 mg/kg/day for six months
Other Intervention Name(s)
prednisolone
Intervention Description
period of therapy
Primary Outcome Measure Information:
Title
Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Biopsy-proven chronic eosinophilic pneumonia Exclusion Criteria: Patients who received oral glucocorticosteroid (more than 10 mg) Immunosuppressive drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kingo Chida, MD, PhD
Organizational Affiliation
Hamamatsu University
Official's Role
Study Chair
Facility Information:
Facility Name
Hamamatsu University School of Medicine
City
Hamamatsu
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25614171
Citation
Oyama Y, Fujisawa T, Hashimoto D, Enomoto N, Nakamura Y, Inui N, Kuroishi S, Yokomura K, Toyoshima M, Yamada T, Shirai T, Masuda M, Yasuda K, Hayakawa H, Chida K, Suda T. Efficacy of short-term prednisolone treatment in patients with chronic eosinophilic pneumonia. Eur Respir J. 2015 Jun;45(6):1624-31. doi: 10.1183/09031936.00199614. Epub 2015 Jan 22.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs