NCT00632554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

1.7 years

First QC Date

February 28, 2008

Last Update Submit

September 18, 2014

Conditions

Eosinophilic PneumoniaChronic Disease

Outcome Measures

Primary Outcomes (1)

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

    Three years

Secondary Outcomes (1)

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

    Three years

Study Arms (2)

1

EXPERIMENTAL

prednisolone therapy for three months

Drug: prednisolone 0.5 mg/kg/day for three months

2

ACTIVE COMPARATOR

prednisolone therapy for six months

Drug: prednisolone 0.5 mg/kg/day for six months

Interventions

prednisolone 0.5 mg/kg/day for three monthsDRUG

period of treatment

Also known as: prednisolone
1
prednisolone 0.5 mg/kg/day for six monthsDRUG

period of therapy

Also known as: prednisolone
2

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy-proven chronic eosinophilic pneumonia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamamatsu University School of Medicine

Hamamatsu, Japan

Location

Related Publications (1)

  • 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.

    PMID: 25614171DERIVED

MeSH Terms

Conditions

Pulmonary EosinophiliaChronic Disease

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kingo Chida, MD, PhD

    Hamamatsu University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Respiratory Medicine

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 10, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

JP(1)