UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036471 |
|---|---|
| Receipt number | R000041386 |
| Scientific Title | Study of the effect of sublingual immunotherapy for Japanese cedar pollinosis and the change of immunoglobulin in blood |
| Date of disclosure of the study information | 2019/04/12 |
| Last modified on | 2019/04/11 11:26:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of the effect of sublingual immunotherapy which is one of the treatment methods of Japanese cedar pollinosis and movement of concentration of protein which carries immunity in blood
Acronym
Study of treatment of cedar pollinosis
Scientific Title
Study of the effect of sublingual immunotherapy for Japanese cedar pollinosis and the change of immunoglobulin in blood
Scientific Title:Acronym
Study of sublingual immunotherapy of Japanese cedar
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we investigated the usefulness of the parameters of serum samples obtained during routine outpatient care from patients undergoing SLIT for Japanese cedar pollinosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
We performed blood sampling and interviews for each patient in January, March, and June 2016.
The patient serum was used to measure 11 items such as IgG4.
Key secondary outcomes
We performed blood sampling and interviews for each patient in January, March, and June 2016.
The patient serum was used to measure 11 items (IgG4,IgE,IL-2,IL-5,IL-10,IL-12p70,IL-17,GM-CSF,VEGF, IFN-g,TGF-b1).
The symptom score are six items, i.e., runny nose, sneezing, stuffy nose, itchy nose, itchy eyes, and watery eyes.
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
We will perform a total of four blood sampling and interviews until June 2016 for patients who have begun cidatoren (the medicine of sublingual immunotherapy for Japanese ceder pollinosis) between June and November 2015.
Treatment is administered daily by the individual patient at home.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are positive for Japanese cedar specific antibody in blood exam
Key exclusion criteria
Patients who are negative for Japanese cedar specific antibody in blood exam
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Takahara |
Organization
Nippon Medical School Musashi Kosugi Hospital
Division name
Department of Oto-Rhino-Laryngology
Zip code
2118533
Address
1-39 Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa
TEL
044-733-5181
eriko.star@gmail.com
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Takahara |
Organization
Nippon Medical School Musashi Kosugi Hospital
Division name
Department of Oto-Rhino-Laryngology
Zip code
2118533
Address
1-39 Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa
TEL
044-733-5181
Homepage URL
eriko.star@gmail.com
Sponsor or person
Institute
Nippon Medical School Musashi Kosugi Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School Musashi Kosugi Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nippon medical school
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Musashi Kosugi Hospital
Address
1-39 Kosugicho, Nakahara-ku, Kawasaki-shi, Kanagawa
Tel
044-733-5181ext.8034
eriko.star@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 12 | 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
29
Results
In the Complete and Poor response group, We compared the changes in the serum cytokines and immunoglobulins levels. There were no changes in the IgG4, IgE, IL-5, IL-10, IFN-g and TGF-b1 levels from January to June in either group. The levels of IL-2 and GM-CSF remained below the limit of detection. The IL-12p70 and VEGF leveis in January, March, and June were slightly higher in the Complete response group. The IL-17 levels in June were significantly higher in the Complete response group.
Results date posted
| 2019 | Year | 04 | Month | 04 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
I am in the process of writing the paper.
It takes time to write the paper.
Date of the first journal publication of results
Baseline Characteristics
Patients with Japanese cedar pollinosis who started treatment with Sidatoren(Sublingual immunotherapy). Men;17 Female;12 average age; 43 years old.
Participant flow
29 cases undergoing SLIT for Japanese Cedar Pollinosis were registered in this study after informed consent for a survey using the Japan rhino-conjunctivitis quality of life questionnaire (JRQLQ) and blood sampling was obtained from each patient.
Adverse events
No obvious adverse events
Outcome measures
Serum levels of cytokines and immunoglobulins in the Complete response group and Poor response group
Plan to share IPD
Shared plan: None
IPD sharing Plan description
Shared plan: None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 11 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041386
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
