UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized, controlled, double-blinded clinical trial of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy
Title of the study (Brief title)	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	Daisuke Murakami
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Otorhinolaryngology
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	Daisuke Murakami
Organization	Graduate School of Medical Sciences, Kyushu University
Division name	Otorhinolaryngology
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 10 Month 01 Day
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

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