Unique ID issued by UMIN | UMIN000013408 |
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Receipt number | R000015648 |
Scientific Title | a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy |
Date of disclosure of the study information | 2014/03/14 |
Last modified on | 2017/02/06 12:24:08 |
a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
an open study of Cry j1-galactomannan conjugate OIT for Japanese cedar pollen allergy
a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
an open study of Cry j1-galactomannan conjugate OIT for Japanese cedar pollen allergy
Japan |
Japanese cedar pollen allergy
Clinical immunology | Oto-rhino-laryngology |
Others
NO
To assess the efficacy of short term OIT using the Cry j1-galactomannan conjugate reduced the risk of anaphylaxis for Japanese cedar pollen allergy by an open trial.
Safety
Confirmatory
Explanatory
Phase II
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).
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.)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is considered as a block.
NO
Numbered container method
2
Treatment
Medicine | Food |
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 6days
3. Cry j1-galactomannan conjugate capsule 3 cap (562.5ug) 2 x (morning 2 cap, evening 1 cap) 6days
4. Cry j1-galactomannan conjugate capsule 4 cap (750ug) 2 x 51days
standard therapy for cedar pollen allergy
using anti-allergic drugs during pollen
season
20 | years-old | <= |
Not applicable |
Male and Female
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 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.
40
1st name | |
Middle name | |
Last name | Daisuke Murakami |
Graduate School of Medical Sciences, Kyushu University
Otorhinolaryngology
Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
092-642-5668
muradai@qent.med.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Daisuke Murakami |
Graduate School of Medical Sciences, Kyushu University
Otorhinolaryngology
Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
092-642-5668
muradai@qent.med.kyushu-u.ac.jp
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University
MEXT(Japan)
Japanese Governmental office
Biobusiness Propulsion Group, Biobusiness Propulsion Division, Wako Filter Technology Co., Ltd.
NO
九州大学病院
2014 | Year | 03 | Month | 14 | Day |
Published
Participants receiving OIT treatment showed significant improvements in total symptom scores, medication score, and total symptom-medication scores through the pollen season compared with control group. The levels of allergen-specific serum IgG4 in individuals were significantly increased in the OIT group, but not the control group through cedar pollen season. Importantly, no severe adverse effects were observed in participants receiving OIT treatment.
(Allergol Int 64:161-168, 2015)
Participants receiving OIT showed significant improvements in the total QOL score and VAS throughout the pollen season compared with the control group. In addition, the mean total QOL score and VAS correlated in both groups during the pollen season.(Auris Nasus Larynx 43: 50-55, 2016)
Completed
2011 | Year | 10 | Month | 01 | Day |
2011 | Year | 10 | Month | 18 | Day |
2013 | Year | 05 | Month | 30 | Day |
2013 | Year | 05 | Month | 30 | Day |
2013 | Year | 05 | Month | 30 | Day |
2014 | Year | 12 | Month | 30 | Day |
2014 | Year | 03 | Month | 13 | Day |
2017 | Year | 02 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015648
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