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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011995
Receipt No. R000013985
Scientific Title Randomized, controlled, double-blinded clinical trial of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
Date of disclosure of the study information 2013/10/17
Last modified on 2018/08/19

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Basic information
Public title Randomized, controlled, double-blinded clinical trial of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
Acronym RCT of Cry j1-galactomannan conjugate OIT for Japanese cedar pollen allergy
Scientific Title Randomized, controlled, double-blinded clinical trial of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
Scientific Title:Acronym RCT 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 Adult
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 RCT.
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 placebo group.
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 total symptom score, each symptom score, medication score, QOL using QOLscore in accordance with The Japanese Allergic Rhinitis QOL Standard Questionnaire No.1 (JRQLQ No1) and VAS through pollen season.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

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, 2014
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 Period of administration
Late March from mid-January, 2014
Dose
1. Placebo capsule 1 cap 1 x 6days
2. Placebo capsule 2 cap 2 x 6days
3. Placebo capsule 3 cap 2 x (morning 2 cap, evening 1 cap) 6days
4. Placebo capsule 4 cap 2 x 51days
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 60

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 Biobusiness Propulsion Group, Biobusiness Propulsion Division, Wako Filter Technology Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

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(福岡県)、済生会福岡総合病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 17 Day

Related information
URL releasing protocol https://www.nature.com/articles/srep46142
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/srep46142
Number of participants that the trial has enrolled
Results Mean symptom-medication score as the primary outcome in the active group improved 27.8% relative to the placebo group during the entire pollen season. As the secondary outcomes, mean medication score in active group improved significantly, by 56.2%, compared with placebo during the entire pollen season. Mean total symptom score was similar between active and placebo groups during the entire pollen season. There were no severe treatment-emergent adverse events in the active and placebo groups.
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 Main results already published
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
2014 Year 04 Month 30 Day
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 09 Day
Last modified on
2018 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013985

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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