UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006354
Receipt number R000007542
Scientific Title Effect of plasmacluster on mild to moderate asthma in children: A randomazed double-blinded trial
Date of disclosure of the study information 2011/09/20
Last modified on 2012/09/17 15:32:56

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Basic information

Public title

Effect of plasmacluster on mild to moderate asthma in children: A randomazed double-blinded trial

Acronym

PLAC study

Scientific Title

Effect of plasmacluster on mild to moderate asthma in children: A randomazed double-blinded trial

Scientific Title:Acronym

PLAC study

Region

Japan


Condition

Condition

asthma

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of Plasmacluster on the airway inflammation levels in mild to moderate asthma in children

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in FeNO levels in the subjects

Key secondary outcomes

Changes in asthmatic symptoms and lung function in the subjects


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

use of Plasmacluster

Interventions/Control_2

use of placebo equipment

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

6 years-old <=

Age-upper limit

19 years-old >

Gender

Male and Female

Key inclusion criteria

Mild to moderate asthmatic patients in whom the diagnosis of asthma has been confirmed; and
1) The age is between 6 and 18 yeras old
2) Positive IgE to house dust mite (Dp and/or Df)

Key exclusion criteria

none

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshio Katsunuma

Organization

Jikei University Daisan Hospital

Division name

Department of Pediatrics

Zip code


Address

4-11-1, Izumi-Honcho, Komae Cty , Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Public Health Research Foundation

Division name

CSP-LD Office

Zip code


Address

1-1-7, Nishi-Waseda, Shinjuku-ku

TEL

03-5287-2633

Homepage URL


Email



Sponsor or person

Institute

Public Health Research Foundation

Institute

Department

Personal name



Funding Source

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2011 Year 09 Month 20 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2011 Year 09 Month 06 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 09 Month 15 Day

Last modified on

2012 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007542


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name