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

UMIN ID: UMIN000001282

Registered date:04/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2008/07/01
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 week intervals.
Two placebo 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 week intervals.

Outcome(s)

• Primary Outcome: nose and eye symptoms
• Secondary Outcome: 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 )

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: TOPIC Study (Trial of OHIO Chamber-Pranlukast Inhibitory Effect for Cedar Exposure-)
• Source(s) of Monetary Support: Public Health Research Foundation