Japanese cedar pollen allergy
Conditions
Interventions
Period of administration Late March from mid-January, 2012 Dose 1. Cry j1-galactomannan conjugate capsule 1 cap (187.5ug) 1 x 6 days 2. Cry j1-galactomannan conjugate capsule 2 cap (375ug) 2 x 6da
Sponsors
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria are described as follows: Participants are Japanese and otherwise healthy but had moderate or severe rhinoconjunctivitis due to JCP allergy and received pharmacological treatment for at least the last 3 consecutive cedar pollen seasons, and lived in and around the city of Fukuoka in Japan, where a similar amount of pollen spread would be expected. The diagnosis of JCP allergy was based on participant clinical history and serum Cry j1-specific IgE levels of score 2 or greater using the CAP-RAST.
Exclusion criteria
Exclusion criteria: Exclusion criteria were as follows: severe asthma, chronic sinusitis, previous immunotherapy or ongoing immunotherapy with other allergens, treatment with B-blockers or participants on continuous corticosteroids, pregnancy or planned pregnancy, participation in another clinical trial, and the standard contraindications for immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total symptom and medication score is averaged total symptom score included 6 kinds of scores, which was 4 points in maximum value plus medication score. During the cedar pollen season, participants recorded their weekly symptoms of rhino conjunctivitis, which were evaluated on a scale from 0 to 4 in accordance with The Japanese Allergic Rhinitis QOL Standard Questionnaire No.1 (JRQLQ No1). The total symptom score is calculated as the sum of each component score as follows: none, 0; mild, 1; moderate, 2; severe, 3; and very severe, 4. Nasal and ocular symptoms covered by the questionnaire included runny nose, sneezing, nasal congestion, itchy nose, itchy eyes and watery eyes and averaged. The total medication score every week during the cedar pollen season is also calculated and averaged per day according to the Practical Guideline for the Management of Allergic Rhinitis, Japan. We determine oral immunotherapy using the Cry j1-galactomannan conjugate is effective if total symptom and medication score of active group is significantly suppressed compared with the control group (the pharmacotherapy group without OIT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral immunotherapy using the Cry j1-galactomannan conjugate starts about one month before Japanese cedar pollen season. Dose is gradually increased to maintenance dose over 18 days. Thereafter, oral immunotherapy is continued for 51 days.We analyze Adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) in v4.0. which are recorded using the questionnaire during Oral immunotherapy to assess the safety. In addition, we assess the cellular components from PBMCs and antigen-specific IgE including cedar, cypress, house dust, and mites in the serum before and after pollen season. we also assess QOL using QOLscore in accordance with The Japanese Allergic Rhinitis QOL Standard Questionnaire No.1 (JRQLQ No1) and VAS through pollen season. In the pollen seaon of next year, we assess the primary and secondary outcomes to clear whether the efficacy of OIT can be maintenanced. (In the first year, immunotherapy group, immunotherapy is not carried out in the next year, oral immunotherapy is performed in the first year the control group in the next year, and comparison is made in the three groups together with each new control group.) | — |
Countries
Japan
Contacts
Public ContactDaisuke Murakami
Graduate School of Medical Sciences, Kyushu University Otorhinolaryngology
Outcome results
None listed