UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of plasmacluster on mild to moderate asthma in children: A randomazed doubleblinded trial
Title of the study (Brief title)	PLAC-study
Region	Japan

Condition
Condition	asthma
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate 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	Confirmatory
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	130

Research contact person
Name of lead principal investigator	Yasuo Ohashi
Organization	School of Integrated Health Science, Faculty of Medicine, The University of Tokyo
Division name	Department of epidemiology and biostatistics
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5841-3520
Email	siitky@gmail.com

Public contact
Name of contact person	Retsu Fujita
Organization	Clinical Research Support Center, The University of Tokyo Hospital
Division name	Central Coordinating unit
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-5800-9762
Homepage URL
Email	retsu-tky@umin.ac.jp

Sponsor
Institute	Clinical Research Support Center, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	SHARP
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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	東京慈恵会医科大学附属第三病院、同愛記念病院、天正堂クリニック天正堂クリニック、おかだこどもの森クリニック、まつもと小児・アレルギークリニック

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 27 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date
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

Management information
Registered date	2013 Year 08 Month 27 Day
Last modified on	2017 Year 02 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013550