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The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber

The effect of early intervention for the patients with Japanese cedar pollinosis in children by Pranlukast dry syrup in the OHIO Chamber - TOPIC-J STUDY 3(Trial of OHIO Chamber Pranlukast inhibitory effect for cedar exposure)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009840
Enrollment
30
Registered
2013-01-26
Start date
2013-01-27
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

Japanese cedar pollinosis in children

Interventions

Pranlukast dry syrup are orally administered to 15 subjects at twice daily two months. Japanese cedar pollen exposure mid-Feb. in OHIO Chamber. Placebo dry syrup are orally administered to 15 subject

Sponsors

Nippon Medical School
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Multiple antigen simultaneous test score against Japanese cedar pollen over class 2 in the past. 2)Have experience with cedar pollen exposure in OHIO Chamber in the past,patients with nasal symptoms with nasal congestion. 3)Patients who were judged to be suitable for patients enrollment by doctor in screening visit or medical examination results. 4)Written informed consent is required.

Exclusion criteria

Exclusion criteria: 1)Some patients with mucosal lesion of the nose and eyes. 2)Patients who received steroid injections within 6 months. 3)Subjects with deformity of the nose polyp. 4)Subjects with systemic diseases(asthma or tuberculosis). 5)Patients with past history of anaphylaxis. 6)Patients who have the hypersensitivity to study drug. 7)Patients who have received immunotherapy. 8)Patients who were judged to be unsuitable for patients enrollment by doctor.

Design outcomes

Primary

MeasureTime frame
Nasal symptoms score

Secondary

MeasureTime frame
1)No of sneezing 2)Nasal secretion volume 3)Occurrence time of the first nasal symptoms 4)Consumption of rescue medicine 5)Eosinophil cationic protein

Countries

Japan

Contacts

Public ContactSatoko Shimizu

Tokyo Reserch Center of Clinical Pharmacology co.,ltd. CRC Section ,Clinical Trial Operations Support Dept.

s-shimizu@trcp.co.jp

Outcome results

None listed

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