UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of lung function decline in chronic eosinophilic pneumonia
Title of the study (Brief title)	Prediction of lung function decline in CEP
Region	Japan

Condition
Condition	Chronic eosinophilic pneumonia
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Prediction of lung function decline in chronic eosinophlic pneumonia
Basic objectives2	Others
Basic objectives -Others	Assessment of long-term outcome in chronic eosinophlic pneumonia
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CLINICAL OUTCOME, PULMONARY FUNCTION TEST
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with chronic eosinophlic pneumonia
Key exclusion criteria	Allergic bronchial pulmonary aspergilosis, eosinophilic granulomatosis with polyangiitis
Target sample size	120

Research contact person
Name of lead principal investigator	TAKAFUMI SUDA
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka 431-3129 Japan
TEL	053-435-2263
Email	yuzosuzu@hama-med.ac.jp

Public contact
Name of contact person	YUZO SUZUKI
Organization	Hamamatsu University School of Medicine
Division name	Second Division, Department of Internal Medicine
Address	1-20-1 Handayama Higashi-ku, Hamamatsu, Shizuoka 431-3129 Japan
TEL	053-435-2263
Homepage URL
Email	yuzosuzu@hama-med.ac.jp

Sponsor
Institute	Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Grant in aid for scientific research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松医科大学第二内科（静岡県）、国立病院機構天竜病院（静岡県）、聖隷三方原病院（静岡県）、磐田市立総合病院（静岡県）、聖隷浜松病院（静岡県）、浜松労災病院（静岡県）、遠州病院（静岡県）、藤枝市立総合病院（静岡県）、静岡市立静岡病院（静岡県）、静岡市立清水病院（静岡県）、静岡県立総合病院（静岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 22 Day
Anticipated trial start date	2015 Year 09 Month 22 Day
Last follow-up date	2016 Year 09 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: multicenter cohort study Objective:Patients with chronic eosinophilic pneumonia, diagnosed at our institute between Jan 2000 to Sep 2015. Measurements:Recurrence, treatments, and pulmonary function tests

Management information
Registered date	2015 Year 09 Month 22 Day
Last modified on	2016 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022075