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Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber

Efficacy of Pranlukast in subjects with Japanese Cedar pollinosis in the OHIO Chamber - TOPIC Study ( Trial of OHIO Chamber - Pranlukast Inhibitory Effect for Cedar Exposure -)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001282
Enrollment
36
Registered
2008-08-04
Start date
2008-07-01
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

Interventions

Two pranlukast capsules are orally administered after the meal 4 times ( 2 times before the exposure and 2 times after the exposure ). The study consists of 2 times exposure in OHIO Chamber at one w

Sponsors

TOPIC Study (Trial of OHIO Chamber-Pranlukast Inhibitory Effect for Cedar Exposure-)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects must have at least a 2-year history of allergic symptoms during the Japanese cedar pollen season, such as sneezing, nasal discharge and nasal obstruction. 2) Subjects must have had blood tests within a 3 years showing positive CAP-RAST scores ( between 2 and 6 ) for Japanese cedar pollen. 3) Subjects must be appropriate to this study by the judgment of doctor. 4) Informed consent must be obtained from the subjects prior to study entry.

Exclusion criteria

Exclusion criteria: 1) Subjects with a polyp or deformity of the nose. 2) Subjects who used steroid drugs for injection within 6 months before the start of this study. 3) Subjects with systemic diseases ( asthma or tuberculosis ). 4) Subjects with build-up phase of immunotherapy to Japanese cedar pollen. 5) Subjects with pregnancy, lactation or potential pregnancy. 6) Subjects who are inappropriate to this study by the judgment of doctor.

Design outcomes

Primary

MeasureTime frame
nose and eye symptoms

Secondary

MeasureTime frame
the number of sneezing, the amount of nasal secretion, the manifestation time of nasal symptoms, nasal airway resistance, respiratory function and performance test( D-CAT )

Countries

Japan

Contacts

Public ContactMinoru Gotoh

Nippon Medical School Chiba Hokusoh Hospital Department of Otolaryngology

0476-99-1111

Outcome results

None listed

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