UMIN-CTR Clinical Trial

Basic information
Public title	Sublingual immunotherapy using imported birch pollen extract for injection
Acronym	Sublingual immunotherapy using imported birch pollen extract for injection
Scientific Title	Sublingual immunotherapy using imported birch pollen extract for injection
Scientific Title:Acronym	Sublingual immunotherapy using imported birch pollen extract for injection
Region	Japan

Condition
Condition	oral allergy syndrome (OAS)
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effectiveness of sublingual immunotherapy using birch pollen extract for oral allergy syndrome (OAS)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary outcome is the change in OAS symptoms after the treatment, which is evaluated by oral food challenge test with numerical rating scale (NRS) before and at some time points after the treatment.
Key secondary outcomes	We also measure nonspecific IgE, specific IgE and specific IgG4 to birch pollen and causative foods before and after the treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Because there is no allergen extract of birch pollen approved for use in therapy at the moment in Japan, we use Birch Mix for injection made by ALK-Abello (USA). We have obtained certification from the ethical committee. Patients hold the drops of the extract sublingually for 2 minutes, and then swallow them, refraining from gargling, drinking and eating for another 5 minutes. Patients are monitored precisely for 30 minutes after ingestion of the extract. This maneuver is started in hospital with rush method. The starting dose is principally 0.1ml of 100-fold dilution of original extract (1:20), and the maneuver is repeated 4 times a day increasing the dose every time possibly up to 0.1ml of original extract. After then, the maneuver is continued at home once daily.
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Persons who have been sensitized with birch pollen (specific IgE>0.7 UA/mL, ImmunoCAP) and suffer from OAS symptoms by ingestion of fruits or vegetables.
Key exclusion criteria	Severe immune abnormality or immunodeficiency, malignancy, severe mental disorder, use of beta blocker, poor compliance, uncontrolled asthma, use of cardiovascular drugs increasing a side effect of the adrenaline, pregnancy, etc..
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Kazuyuki Middle name Last name Kurihara
Organization	Kanagawa Children's Medical Center
Division name	Department of Allergy
Zip code	2328555
Address	2-138-4, Mutsukawa, Minami-ku, Yokohama-shi, Kanagawa
TEL	045-711-2351
Email	kkurihara@msb.biglobe.ne.jp

Public contact
1st name of contact person	1st name Shuntaro Middle name Last name Tsumagari
Organization	Kanagawa Children's Medical Center
Division name	Department of Allergy
Zip code	2328555
Address	2-138-4, Mutsukawa, Minami-ku, Yokohama-shi, Kanagawa
TEL	045-711-2351
Homepage URL
Email	stsumagari@kcmc.jp

Sponsor
Institute	Kanagawa Children's Medical Center Department of Allergy
Institute
Department

Funding Source
Organization	Kanagawa Children's Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research ethics committee, Kanagawa Children's Medical Center
Address	2-138-4, Mutsukawa, Minami-ku, Yokohama-shi, Kanagawa
Tel	0457112351
Email	kcmcrinri@kanagawa-pho.jp

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	神奈川県立こども医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	1
Results
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	2016 Year 01 Month 31 Day
Date of IRB	2016 Year 02 Month 05 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 10 Month 12 Day
Last modified on	2019 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028064