UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015603 |
|---|---|
| Receipt number | R000018128 |
| Scientific Title | Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy with Japanese cedar pollen extract. - A randomized controlled trial for the subjects with positive sensibilization having not symptoms - |
| Date of disclosure of the study information | 2014/11/04 |
| Last modified on | 2019/02/19 05:56:23 |
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Basic information
Public title
Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy with Japanese cedar pollen extract. - A randomized controlled trial for the subjects with positive sensibilization having not symptoms -
Acronym
Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy
Scientific Title
Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy with Japanese cedar pollen extract. - A randomized controlled trial for the subjects with positive sensibilization having not symptoms -
Scientific Title:Acronym
Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether second intervention by sublingual immune therapy for the subjects with positive sensitization having not symptoms inhibits development of cedar pollinosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Ratio of onset of Japanese cedar pollinosis(1 and 2)
1.Increasing of nasal symptom score in the peak pollen season
2.affirmation of symotoms by cedar pollen antigen provocation test after cedar pollen scattering
Key secondary outcomes
1.Increasing of nasal symptom score in the peak pollen season.
2.Affirmation of symotoms by cedar pollen antigen provocation test after cedar pollen scattering
3.Adherence of sublingual immunotherapy
4.Safty
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
From December 2014 to Apirl 2015, patients of control 1 receive active treatment everyday. The induction/build-up phase is 2 weeks,with an increasing daliy number of the extract drops at two consentrations.
Same treatmet is conducted from December 2015 to April 2016 and from December 2016 to April 2017.
Interventions/Control_2
From December 2014 to April 2015, patients of control 2 receive placebo everyday. The induction/build-up phase is 2 weeks,with an increasing daliy number of the placebo drops as control 1.
Same treatmet is conducted from December 2015 to April 2016 and from December 2016 to April 2017.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)There is not medical history of cedar pollinosis
2)Positive specific IgE to cry j1/2 antigen(ImmunoCAP>=class2)
3)No affirmation of symotoms by cedar pollen antigen provocation test before entering the examination.
Key exclusion criteria
1)Severe asthma
2)Malignat disease or immmun disorder
3)Severe heart disease, lung deisease and hypertension
4)Using of systemic steroid
5)Perennial allregic rhinitis for which treatment is required
6)Complication of the other nasal-paranasal disease which influence the effect of SLIT
7)Using of drug which influence the effect of SLIT
8)Pregnant women and those at risk of pregnancy
9)lactating woman
10)The patients who the doctor judged inaproppriate for the study
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
yoakamoto@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Homepage URL
syonekura@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Reseach and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 11 | Month | 04 | 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
Results
169 cases were partipated in the trial. The Active group was 79 cases in the FAS, and the onset was 1.3%. In contrast, the placebo group was 2.6% of onset in 77 cases. The statistical significant difference of the ratio of the onset was not recognized.
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
| 2014 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 04 | Day |
Last modified on
| 2019 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018128
| Research Plan | |
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