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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024376
Receipt No. R000028064
Scientific Title Sublingual immunotherapy using imported birch pollen extract for injection
Date of disclosure of the study information 2016/12/01
Last modified on 2019/04/17

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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
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
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

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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