UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024376
Receipt number 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 10:37:03

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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 or person

Institute

Kanagawa Children's Medical Center Department of Allergy

Institute

Department

Personal name



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

Value
https://center6.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