UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030830
Receipt number R000035189
Scientific Title Steroids inhalation therapy in chronic eosinophilic pneumonia
Date of disclosure of the study information 2018/01/16
Last modified on 2018/01/16 09:44:00

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Basic information

Public title

Steroids inhalation therapy in chronic eosinophilic pneumonia

Acronym

Eosinophilic pneumonia

Scientific Title

Steroids inhalation therapy in chronic eosinophilic pneumonia

Scientific Title:Acronym

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

1st name
Middle name
Last name Norihide Murayama

Organization

Murayama Pediatrics

Division name

Pediatrics

Zip code


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

1st name
Middle name
Last name Norihide Murayama

Organization

Murayama Pediatrics

Division name

Pediatrics

Zip code


Address

3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka

TEL

06-6790-8835

Homepage URL


Email

norihide99@yahoo.co.jp


Sponsor or person

Institute

Murayama Pediatrics

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


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 %).

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

1999 Year 12 Month 31 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035189


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name