UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011589 |
|---|---|
| Receipt number | R000013550 |
| Scientific Title | Effect of plasmacluster on mild to moderate asthma in children: A randomazed doubleblinded trial |
| Date of disclosure of the study information | 2013/08/27 |
| Last modified on | 2017/02/27 10:48:37 |
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Basic information
Public title
Effect of plasmacluster on mild to moderate
asthma in children: A randomazed doubleblinded
trial
Acronym
PLAC-study
Scientific Title
Effect of plasmacluster on mild to moderate
asthma in children: A randomazed doubleblinded
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 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
| 1st name | |
| Middle name | |
| Last name | Yasuo Ohashi |
Organization
School of Integrated Health Science, Faculty of Medicine, The University of Tokyo
Division name
Department of epidemiology and biostatistics
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5841-3520
siitky@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Retsu Fujita |
Organization
Clinical Research Support Center, The University of Tokyo Hospital
Division name
Central Coordinating unit
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5800-9762
Homepage URL
retsu-tky@umin.ac.jp
Sponsor or person
Institute
Clinical Research Support Center, The University of Tokyo Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
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
| 2013 | Year | 05 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013550
