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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008418
Receipt No. R000009506
Scientific Title Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)
Date of disclosure of the study information 2012/07/17
Last modified on 2012/07/12

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Basic information
Public title Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)
Acronym Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)
Scientific Title Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)
Scientific Title:Acronym Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)
Region
Japan

Condition
Condition Asthma
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It observes about the control state of uncontrolled asthmatic children treated by ICS and a LTRA combined therapy.
one group changed LTRA into IPD without the increasing the quantity of ICS ,
and other group increased the quantity of ICS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of chang of the asthma symptom score at the time of registration and the score at twelve week later.(The score made by the comittee of asthma severity judging standard of Japanese society of Allergology.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The group which changed LTRA into IPD without the increasing the quantity of ICS . (A group)
Before randomization ,The group is continuing the combined therapy of LTRA and ICS for four weeks or more before a temporary registration date. and "the apparent severity of illness" of JPGL 2008 of the group is more than mild persistent asthma and the control state of the group is bad by a JPAC questionnaire .
Interventions/Control_2 The group which increased the quantity of ICS 1.5 to 2.0 times (group B)
Before randomization ,The group is continuing the combined therapy of LTRA and ICS for four weeks or more before a temporary registration date. and "the apparent severity of illness" of JPGL 2008 of the group is more than mild persistent asthma and the control state of the group is bad by a JPAC questionnaire .
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
2 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 1. Case in which ICS and LTRA combined therapy were persisting four weeks or more.
2. "The apparent severity of illness" of JPGL 2008 is more than mild persistent asthma.
3.Case which receive Step 2 or Step 3 therapy based on JPGL2008.
4. Case as which control was poor and increase in quantity of medicine was considered as a result of judgment using JPAC questionnaire.
5.The case with which the selection criterion No2 and No3 are filled even if it sets the observation period for 4 weeks.
6. The age at the time of temporary registration is more than 2 years old and less than 15 years old
Key exclusion criteria 1. Case which has anamnesis of hypersensitivity to spulatast tosilate.
2. Case which is using Symbicoat or Adair .
3. Case which newly uses systemic steroid from temporary registration date.
4. Case which receive newly hyposensitization or nonspecific immnotherapy from temporary registration date.
5. Case which has impaired liver function.
6. Case considered that there are complications, such as chronic bronchitis, pulmonary emphysema, and bronchiectasis, and it interferes with judgement of effect of a medicine .
7. In addition, case which has serious illness complications.
8. In addition, case which family doctor judged to be unsuitable as experimental object.
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Kameda
Organization Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Division name Pediatrics
Zip code
Address 3-7-1 Habikino Habikino City Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Prefectural Medical Center for Respiratory and Allergic Disease
Division name Pediatrics
Zip code
Address 3-7-1 Habikino Habikino City Osaka
TEL
Homepage URL
Email

Sponsor
Institute Study group of the treatment of childfood asthma
Institute
Department

Funding Source
Organization Japan Allergy 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
2012 Year 07 Month 17 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 Open public recruiting
Date of protocol fixation
2012 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 17 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
2012 Year 07 Month 12 Day
Last modified on
2012 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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