The Efficacy of Three Months-Prednisolone Therapy for Chronic Eosinophilic Pneumonia - Tabular View

Tracking Information

First Received Date ^ICMJE

February 28, 2008

Last Updated Date

February 27, 2009

Start Date ^ICMJE

June 2007

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Efficacy of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: three-year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00632554 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: Three years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Safety of 3 versus 6 months-prednisolone therapy for chronic eosinophilic pneumonia [ Time Frame: three-year ] [ Designated as safety issue: Yes ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 4, Randomized Study of Three Months-Prednisolone Therapy in the Treatment of Chronic Eosinophilic Pneumonia

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Eosinophilic Pneumonia
Chronic Disease

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: prednisolone therapy for three months
Active Comparator: prednisolone therapy for six months

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

March 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Biopsy-proven chronic eosinophilic pneumonia

Exclusion Criteria:

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

Gender

Both

Ages

16 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Naoki Inui, MD, PhD

81-53-435-2385

may15@hama-med.ac.jp

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00632554

Responsible Party

Hamamatsu University School of Medicine, Respiratory Medicine, Hamamatsu University School of Medicine, Respiratory Medicine

Study ID Numbers ^ICMJE

Hamamatsu-18-67

Study Sponsor ^ICMJE

Hamamatsu University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Kingo Chida, MD, PhD

Hamamatsu University

Information Provided By

Hamamatsu University

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP