Adult patient with Japanese cedar pollinosis.
Conditions
Interventions
Evaluation on the safety of 80g of transgenic rice containing peptides from Japanese cedar pollen allergens among few subjects.
Evaluation of the safety and efficacy of 80g of transgenic rice containi
Sponsors
The Jikei University, School of Medicine
National Institute o Agrobiological Sciences (NIAS) SATAKE Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult aged over 20years old and lives or works in Tokyo. 2) P person who has allergic symptoms such as sneezing, running nose, and nasal obstruction. 3) A person who gives a positive result in provocative test and intradermal test (please refer to appendix for an assessment procedures) 4) Cedar pollen allergen-specific IgE antibody values over Class II. 5) Cypress specific IgE antibody values under Class IV.
Exclusion criteria
Exclusion criteria: 1) A person who is allergic to Rice or has a history of Rice allergy. 2) A person who shows Pet/House dust specific IgE antibody valued over Class V, and has pet (dogs and cats). 3) A person who is imperative to use medicine such as anti-allergic agent and steroidal chemicals that potentially influence the outcome of evaluation. 4) A person who underwent an operation that is accompanied to nasal disorder within last 2years, or has nasal disorder such as acute/chronic-rhinitis, rhinopolypus, hypertronic rhinitis, septal deviation, sinusitis which all are potentially hinder to the outcome of evaluation. 5) A person who ever received immunotherapy in the past. 6) A person who has any disorders under treatment and the condition is unstable that trial investigator has asessed as mismatched participant. 7) A person who has a history of serious disorder such as diabetes, hepatic disorder, kidney disorder, and cardiac disorder. 8) A person who takes beta-blocker in order to treat complecating disorders such as hypertension, and / or cardiac disorder. 9) A person who takes alpha-blocker in order to treat complecating disorders such as prostatic hyperplasia. 10) A person who is complecated by immunodeficiency disorder, cancer, or severe enemia. 11) A person who is complecated by severe asthma. 12) A person who'S pre-clinical test showed AST(GOT), ALT(GRT), Creatinine or BUN value exceed 1.5 times the upper limit or normal, or has other laboratory abonormalities that trial investigator has assessed as mismatched participant. 13) A person who participates in other clinical test at the onset of this test. 14) A person who is presently breastfeeding, pregnant, or planning/wishing to be a pregnant during a period of this clinical test. 15) A person whom trial investigator has asessed as mismatched participant.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Efficacy **Following items are to be compared in between BEFORE and AFTER the pollination season** - Total score of intranasal observation - Total score of intradermal reaction and number of nasal eosinophil - Immunological test (Change of reactive T-cell) - Score of Japanese Allergic Rhinitis Standard QOL Questionnaire (JRQLQ) - Total score of nasal symptoms (Sneezing score, Nasal secretion score, and Nasal congestion score) reported by allergic diary Safety - Subjective symptom and Objective symptom (medical interview, allergic diary) - Changes in laboratory values | — |
Primary
| Measure | Time frame |
|---|---|
| Based on the group of placebo rice ingestion as a reference, evaluate the difference in sum of severity degree of nasal symptoms such as sneezing, nasal secretion, and nasal congestion to be compared between BEFORE and AFTER the pollination season. Furthermore, according to the information of the biggining day of cedar pollination spread, announced on the pollen report site of Ministery of the Environment (http://www.env.go.jp/chemi/anzen/kafun/) | — |
Countries
Japan
Contacts
Public ContactDaiya Asaka
The Jikei University, School of Medicine. Dpartment of Otorhinolaryngology
Outcome results
None listed