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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015603
Receipt No. 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

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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
Last 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
Email yoakamoto@faculty.chiba-u.jp

Public contact
1st 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
Email syonekura@faculty.chiba-u.jp

Sponsor
Institute Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018128

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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