Unique ID issued by UMIN | UMIN000015603 |
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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 |
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 -
Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy
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 -
Study for the prevention of Japanese cedar pollinosis by sublingual immunotherapy
Japan |
Japanese cedar pollinosis
Oto-rhino-laryngology |
Others
NO
To clarify whether second intervention by sublingual immune therapy for the subjects with positive sensitization having not symptoms inhibits development of cedar pollinosis.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
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
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Medicine | Vaccine |
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.
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.
18 | years-old | <= |
65 | years-old | > |
Male and Female
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.
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
180
1st name | |
Middle name | |
Last name | Yoshitaka Okamoto |
Chiba University Graduate School
Department of Otorhinolaryngology
1-8-1 Inohana,Chuo-ku Chiba 260-8677
043-222-7171
yoakamoto@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Syuji Yonekura |
Chiba University Graduate School
Department of Otorhinolaryngology
1-8-1 Inohana,Chuo-ku Chiba 260-8677
043-222-7171
syonekura@faculty.chiba-u.jp
Department of Otorhinolaryngology in Ciba University Graduate School
Japan Agency for Medical Reseach and Development
Japanese Governmental office
NO
2014 | Year | 11 | Month | 04 | Day |
Unpublished
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.
Completed
2014 | Year | 10 | Month | 24 | Day |
2014 | Year | 11 | Month | 04 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 06 | Month | 01 | Day |
2018 | Year | 06 | Month | 15 | Day |
2014 | Year | 11 | Month | 04 | Day |
2019 | Year | 02 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018128
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