UMIN-CTR Clinical Trial

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

Asthma

Classification by specialty

Pediatrics

Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Study group of the treatment of childfood asthma

Institute

Department

Personal name

Organization

Japan Allergy Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

07

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2012

Year

07

Month

12

Day

Last modified on

2012

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009506