WAL801CL (Epinastine Hydrochloride) Dry Syrup in Paediatric Perennial Allergic Rhinitis

Inclusion criteria

• 15 years of age or younger
• Body weight of 14 kg or more
• Typical symptoms of perennial allergic rhinitis, and within 2 or higher score of serum specific immunoglobulin E (IgE) caused by house dust (HD) or mite in the data obtained with the past one year
• "Moderate" or "Severe" in the Allergic Rhinitis Severity Classification during the observation period
• The Patient Diary can be entered by the patient or parent
• Outpatients

Exclusion criteria

• Absolute necessity of treatment with a drug that may affect the evaluation of the effect of the investigational drug (e.g., anti-histamines, anti-allergics, steroid, vasopressors). Patients being treated with the following drugs, however, may be included

• Intal® Oral or Inhalation
• Any eye drops other than Zaditen® Eye Drop
• External preparations (liniment, poultice)
• Initiation of desensitisation therapy within the past 6 months
• Onset of acute upper respiratory inflammation during the observation period
• Nasal disease, such as acute or chronic rhinitis, nasal polyp, hypertrophic rhinitis, septal deviation*, sinusitis*, and hypertrophied adenoid*, of such a degree that the disease affects evaluation of the effect of the test drug (*: X-ray examination will be conducted if necessary)
• That pollen (cider, ragweed, Japanese cypress, orchard grass, etc.) is a double antigen, and that the study will be conducted in the season of air-borne pollen, and symptoms may be exacerbated by pollen
• Present or past history of a convulsive disease, such as epilepsy (convulsion threshold values may be decreased by the comparator drug, ketotifen fumarate)
• Clinically significant abnormal changes in laboratory measurements, and thus judgement that the patient is ineligible for inclusion in this study; however, if the patient is judged as falling into Grade 2 or more according to the MHW (Ministry of health and welfare) Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study
• Clinically significant renal, hepatic or cardiac disease, or other complications, and thus judgement that the patient is ineligible for inclusion in the study; however, if the patient is judged as falling into Grade 2 or more according to the MHW Adverse Reaction Severity Classification Criteria, the patient will be excluded from the study
• Past history of drug allergy
• 1 month, or 6 times as long as the half life of the investigational drug if it is over 1 month, will not have passed since participation in any other clinical trial study, at the time of the initiation of this study
• Judgement by the Principal Investigator or Investigator that the patient is ineligible for inclusion in this study