Clinical efficacy and safety of sublingual immunotherapy in patients with Japanese cedar pollinosis.A double-blind,placebo-controlled study.

UMIN ID: UMIN000000709

Registered date:07/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 2006/09/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

From September 2006 to May 2008,patients of control 1 receive active treatment once weekly.The induction/build-up phase is 3 weeks,with an increasing daliy number of the extract drops at three consentrations.
From September 2006 to May 2008,patients of control 2 receive placebo once weekly.The induction/build-up phase is 3 weeks,with an increasing daliy number of the placebo drops as control 1.

Outcome(s)

• Primary Outcome: Symptom-medication score
• Secondary Outcome: 1)Adverse event 2)Evaluation of biomarker

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: 1)The history of severe asthma 2)The history of anti-allergic drugs within 4 weeks 3)Perior history of immunotherapy with cedar pollen 4)Pregnant women and those at risk of pregnancy 5)Complication of the other nasal-paranasal disease

Related Information

• Primary Sponsor: Department of Otorhinolaryngology in Ciba University Graduate School
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare