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Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)

Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy) - Effect of suplatast tosilate for moderate to severe uncontrolled asthmatic children who treated by ICS and LTRA(SMAC sutudy)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008418
Enrollment
42
Registered
2012-07-17
Start date
2012-07-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

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
the apparent severity of illness&quot
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 . The group which increased the quantity of ICS 1.5 to 2.0 times (grou
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 .

Sponsors

Study group of the treatment of childfood asthma
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026