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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013408
Receipt No. 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

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Basic information
Public title a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
Acronym an open study of Cry j1-galactomannan conjugate OIT for Japanese cedar pollen allergy
Scientific Title a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
Scientific Title:Acronym an open study of Cry j1-galactomannan conjugate OIT for Japanese cedar pollen allergy
Region
Japan

Condition
Condition Japanese cedar pollen allergy
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes 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).
Key secondary outcomes 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.)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 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
Interventions/Control_2 standard therapy for cedar pollen allergy
using anti-allergic drugs during pollen
season
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Murakami
Organization Graduate School of Medical Sciences, Kyushu University
Division name Otorhinolaryngology
Zip code
Address Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5668
Email muradai@qent.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Murakami
Organization Graduate School of Medical Sciences, Kyushu University
Division name Otorhinolaryngology
Zip code
Address Maidashi 3-1-1 Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5668
Homepage URL
Email muradai@qent.med.kyushu-u.ac.jp

Sponsor
Institute Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Biobusiness Propulsion Group, Biobusiness Propulsion Division, Wako Filter Technology Co., Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results 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)
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 18 Day
Last follow-up date
2013 Year 05 Month 30 Day
Date of closure to data entry
2013 Year 05 Month 30 Day
Date trial data considered complete
2013 Year 05 Month 30 Day
Date analysis concluded
2014 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 03 Month 13 Day
Last modified on
2017 Year 02 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015648

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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