Grass Pollinosis
Conditions
Interventions
To conduct a randomized, double-blind, placebo-controlled trial of TO-209 sublingual administration in patients 5-64 years of age with grass pollinosis to verify the superiority of TO-209 to placebo u
Sponsors
Kikuchi Masayo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Men and women aged >= 5 years to = Class 2" and "positive skin prick test (Timothy) 2) "Orchard pollen-specific IgE antibody test >= Class 2" and "positive skin prick test (Orchard)". -Patients who experienced any moderate to severe nasal symptoms of nasal discharge, nasal congestion, sneezing, or pruritus (with a total nasal symptom score of >= 7) as well as any mild to severe ocular symptoms of foreign body sensation/hyperemia/pruritus in the eye or lacrimation (with a total ocular symptom score of >= 1) in locations with weeds, such as dry riverbeds, fields, farmlands, and vacant lots, during the grass pollen season (Hokkaido: Jun, Tohoku, Kanto, Chubu, Kinki, Chugoku, Shikoku, Kyushu: May-Jun) for >= 2 years consecutively, including the year of the starting day of observation (Visit 1), and who required drug therapy.
Exclusion criteria
Exclusion criteria: -Patients with specific IgE antibody test results of Class 5 or higher for any of the following: Japanese cypress, alder, white birch, ragweed, Dermatophagoides pteronyssinus, dog dander, cat dander, cockroach, moth, Candida, Aspergillus, and Alternaria measured on the starting day of observation (Visit 1) -Patients with specific IgE antibody test results of Class 2-4 for dog dander and cat dander measured on the starting day of observation (Visit 1) who experienced allergic rhinitis due to the antigens -Patients with specific IgE antibody test results of Class 2-4 for dog dander and cat dander measured on the starting day of observation (Visit 1) who showed no symptoms of allergic rhinitis due to the antigens while being exposed to the animals on a daily basis (e.g., have a dog(s)/cat(s) at home, work at a pet shop) -Patients having daily contact with the pet(s) fed by timothy and/or orchard -Patients who experienced seasonal allergic rhinitis or conjunctivitis symptoms caused by other allergens during the grass pollen season (between May and June) and required medication -Patients with comorbidities such as drug-induced rhinitis, vasomotor rhinitis, or non-allergic rhinitis -Patients with following asthma; 1) Asthma requiring high daily doses of inhaled corticosteroids within 6 months prior to the randomisation (Visit 2) 2) Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 6 months prior to randomisation (Visit 2) -Patients who received specific or non-specific immunotherapy for grass pollinosis, as indicated below: 1) Patients who received specific immunotherapy for grass pollinosis for at least 1 month within 5 years before the starting day of observation (Visit 1) 2) Patients who received non-specific immunotherapy between 5 years before the starting day of observation (Visit 1) and the starting day of observation (Visit 1) 3) Patients who have initiated specific immunotherapy for allergic symptoms caused by mite allergens within 1 year before the starting day of observation (Visit 1) 4) Patients who have initiated specific immunotherapy for allergic symptoms caused by Japanese cedar pollen in 2025
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average daily Total combined rhinoconjunctivitis symptom score and rhinoconjunctivitis medication score during period A | — |
Secondary
| Measure | Time frame |
|---|---|
| -Average daily Total combined rhinoconjunctivitis symptom score and rhinoconjunctivitis medication score during period B -Average daily rhinoconjunctivitis score during period A, period B -Average daily rhinoconjunctivitis medication score during period A, period B -Average daily rhinitis score during period A, period B -Average daily rhinitis medication score during period A, period B -Average daily Total combined rhinitis score during period A, period B -Average daily conjunctivitis score during period A, period B -Average daily conjunctivitis medication score during period A, period B -Average daily Total combined conjunctivitis score during period A, period B -JRQLQ No.1 (23-May-2026, 23-Jun-2026) -Physician's and subject's global evaluation | — |
Contacts
Public ContactMasayo Kikuchi
Torii Pharmaceutical Co.,Ltd
Outcome results
None listed