UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Steroids inhalation therapy in chronic eosinophilic pneumonia
Title of the study (Brief title)	Eosinophilic pneumonia
Region	Japan

Condition
Condition	Eosinophilic pneumonia
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine lebel and site of inflamation in lung.
Basic objectives2	Others
Basic objectives -Others	Efficacy of ICS in Eosinophilic Pnemonia.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	CD25 expression on CD4-positive T-lymphocytes was also increased (25.5 %) in the BALF compared to that on those in the peripheral blood (15.5 %).
Key secondary outcomes	We tried many ICSs on remmission and acute phase but obtained enough effect in eosinophilic pneumonia.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	In December 1999, a 15-year-old girl was referred to Habikino hospital for evaluation of respiratory symptoms. BALF, Peripheral blood.process of treatments with ICS.
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	Not applicable
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Eosinophilic pneumonia, a case report.
Key exclusion criteria	Nothing
Target sample size	1

Research contact person
Name of lead principal investigator	Norihide Murayama
Organization	Murayama Pediatrics
Division name	Pediatrics
Address	3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka-shi Osaka Japan
TEL	06-6790-8835
Email	norihide99@yahoo.co.jp

Public contact
Name of contact person	Norihide Murayama
Organization	Murayama Pediatrics
Division name	Pediatrics
Address	3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka
TEL	06-6790-8835
Homepage URL
Email	norihide99@yahoo.co.jp

Sponsor
Institute	Murayama Pediatrics
Institute
Department

Funding Source
Organization	Murayama Pediatrics
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	1999 Year 12 Month 31 Day
Anticipated trial start date	1999 Year 12 Month 31 Day
Last follow-up date	2004 Year 07 Month 31 Day
Date of closure to data entry	2004 Year 07 Month 31 Day
Date trial data considered complete	2004 Year 07 Month 31 Day
Date analysis concluded	2004 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Eosinophils were increased in both the BALF (65 %) and peripheral blood (33 %). HLADR expression was increased on CD4-positive T-lymphocytes in the BALF (62.8 %) compared to that on those in the peripheral blood (6.4 %). CD25 expression on CD4-positive T-lymphocytes was also increased (25.5 %) in the BALF compared to that on those in the peripheral blood (15.5 %).
Other related information	We tried some ICS therapies for more than ten years. But I could not gain expected effect by any inhaled steroids.

Management information
Registered date	2018 Year 01 Month 16 Day
Last modified on	2018 Year 01 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035189