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

NCT ID: NCT00632554

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Eosinophilic Pneumonia Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

prednisolone therapy for three months

Group Type EXPERIMENTAL

prednisolone 0.5 mg/kg/day for three months

Intervention Type DRUG

period of treatment

2

prednisolone therapy for six months

Group Type ACTIVE_COMPARATOR

prednisolone 0.5 mg/kg/day for six months

Intervention Type DRUG

period of therapy

Interventions

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prednisolone 0.5 mg/kg/day for three months

period of treatment

Intervention Type DRUG

prednisolone 0.5 mg/kg/day for six months

period of therapy

Intervention Type DRUG

Other Intervention Names

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prednisolone prednisolone

Eligibility Criteria

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Inclusion Criteria

* Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria

* Patients who received oral glucocorticosteroid (more than 10 mg)
* Immunosuppressive drug
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamamatsu University

OTHER

Sponsor Role lead

Responsible Party

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Naoki Inui

Department of Respiratory Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kingo Chida, MD, PhD

Role: STUDY_CHAIR

Hamamatsu University

Locations

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Hamamatsu University School of Medicine

Hamamatsu, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 25614171 (View on PubMed)

Other Identifiers

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Hamamatsu-18-67

Identifier Type: -

Identifier Source: org_study_id

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