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
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
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
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
