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
Phase 3
- Conditions
- Japanese cedar pollinosis
- Registration Number
- JPRN-UMIN000015603
- Lead Sponsor
- Department of Otorhinolaryngology in Ciba University Graduate School
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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