Seasonal allergic rhinitis
Conditions
Interventions
Rupatadine 10mg per day for 10 days Add another rupatadine 10mg from the 6th day if the patient is not satisfied with the treatment.
Sponsors
Medical Corporation Shinanokai, Shinanozaka Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) At the time of the agreement 1) Males and females aged 20-59 years. 2) Patient who has allergic symptoms during Japanese cedar pollen season for at least the past two years. 3) Patient who is dissatisfied with anti-histamine treatment in the last year. 4) Written informed consent is required. (2) At the time of the registration 1) Patients with positive specific IgE antibody for Japanese cedar pollen. 2) Patient who has 4 nasal symptoms (sneezing, nasal discharge, nasal obsrtuction, and nasal itching), and total nasal symptom score (the sum of each nasal symptom score) is more than 6 in average (18 points in total) three days before treatment. 3) Patient who is dissatisfied with symptoms of seasonal allergic rhinitis at the start of the study. 4) Patient who can fill in a patient diary adequately and exactly.
Exclusion criteria
Exclusion criteria: 1) Patient with nasal disorders and/or infectious diseases. 2) Patient with non-allergic rhinitis. 3) Patient who underwent nasal surgery, including laser or coagulation surgery to improve nasal symptoms for less than one year before the agreement. 4) Patient with uncontrolled asthma. 5) Patient who has the hypersensitivity to antihistamine including rupatadine. 6) Following medications and treatments are prohibited before the start of the study. Antihistamine, leukotriene receptor antagonist, anti-thromboxane A2, and any antirhinitis medications. Steroid preparation (oral, injection, inhalation, and nasal drop), vasoconstictor (eye or nasal drop), parasympathetic nerve blocker (anti-cholinergic drug), biological preparation, immunosuppressive drug and any other drugs with similar pharmacological properties (eg Chinese herbal medicine), laser surgery, coagulation surgery, and nasal irrigation with normal saline. 7) Patient who is undergoing immunotherapy. 8) Patient with a liver or renal dysfunction. 9) Patient with severe complications. 10)Pregnant women or breast-feeding women, and patients who may be pregnant. 11) Patient who is judged to be ineligible for participation in the study by the clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment satisfaction of the patient on the 11th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Total nasal symptom score 2) Night nasal congestion score 3) QOL score | — |
Countries
Japan
Contacts
Public ContactSatoko Shimizu
Tokyo Research Center of Clinical Pharmacology co.,ltd Clinical trial promotion II dept.
Outcome results
None listed