Allergic rhinitis
Conditions
Interventions
investigational material(s)
Generic name etc : TO-203
INN of investigational material : -
Therapeutic category code : 449 Other antiallergic agents
Dosage and Administration for Investigational materi
Sponsors
TORII PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with HDM-specific IgE : class 3 or more. (2) Patients with positive nasal provocation test. (3) Patients with a history of prescription drug treatment for perennial allergic rhinitis. (4) Patients with moderate or severe symptoms of HDM-induced allergic rhinitis.
Exclusion criteria
Exclusion criteria: (1) Patients with class 5 or more in the specific-IgE antibody tests to any of the following: cedar, cypress, alder, Betula, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog dander, or cat dander. (2) Patients with class 2 to 4 in the specific-IgE antibody tests to any of the following: cedar, cypress, alder, Betula, cocksfoot, ragweed, mugwort, Japanese hop, cockroach, Candida, Aspergillus, Alternaria, dog dander, or cat dander, and who have symptoms of allergic rhinitis due to these relevant antigen (3) Patients with class 2 to 4 in the specific-IgE antibody tests to dog dander or cat dander, and who have no symptoms of allergic rhinitis, while being constantly exposed to these relevant animal (e.g., pet parenting at home)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Total Combined Rhinitis Score(TCRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Daily Symptom Score (DSS) of allergic rhinitis safety Incidences of adverse event(s) and adverse drug reaction(s) | — |
Countries
Japan
Outcome results
None listed