UMIN-CTR Clinical Trial

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

Japanese cedar pollen allergy

Classification by specialty

Clinical immunology	Oto-rhino-laryngology	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Biobusiness Propulsion Group, Biobusiness Propulsion Division, Wako Filter Technology Co., Ltd.

Name of secondary funder(s)

MEXT(Japan)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院（福岡県)、済生会福岡総合病院（福岡県）

Date of disclosure of the study information

2013

Year

10

Month

17

Day

URL releasing protocol

https://www.nature.com/articles/srep46142

Publication of results

Published

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

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 related information

Registered date

2013

Year

10

Month

09

Day

Last modified on

2018

Year

08

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013985