None listed
Conditions
Interventions
Drug : Only those who are eligible for the inclusion and exclusion criteria. Stratification will be be performed according to the presence or absence of asthma disease. A randomization will be be per
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who are over 6 years old and under 14 years old; 2. Those who have received written consent from the legal representative 3. Patients with allergic rhinitis symptoms and positive for Skin Prick or Specific IgE Test - Allergic rhinitis symptoms: two or more of the four symptoms of nasal discharge, congestion, sneezing and pruritus - Specific IgE Test positive criteria: =0.35 KU/L or Class 1 or higher. - Skin Prick Test positive criteria : A or B criteria are satisfied A. the size of the swelling obtained from the Allergen stimulation is greater than or equal to 3 mm B. The size of the swelling obtained from the Allergen stimulation is equal to or greater than the size of the swelling obtained from the histamine solution (1 mg/ml or 0.1% histamine solution) stimulation 4. Those who meet one of the criteria for rhinitis symptoms ? at the time of Visit 1 - Those who have a total of 6 or more daytime nasal symptom score during the day for 4 days prior to the visit 1 ? at the time of Visit 2 - A person whose nasal symptom score during the daytime recorded in the subject's diary within a maximum of 9 days is a total of 6 points or more per day (maximum of 12 points) - A person who records the Daytime nasal symptom score for 4 days or more in the test subject's diary within a maximum of 9 days 5. For asthmatic patients, diagnosed with asthma by investigators
Exclusion criteria
Exclusion criteria: 1. Persons accompanied by rhinitis findings (vessel motility, infectivity, drug derivation) of other non-allergic causes 2. Severe asthma sufferers: - In case of an emergency room with asthma within one month or within three months of visiting date of Visit 1 - Asthma patients who need a treatment other than an effective bronchial dilator 3. Person with nasal polyp or clinically important nose deformity 4. Those with flu-containing infections and systemic infections within two weeks prior to Visit 1 5. Those with acute and chronic sinusitis within one month prior to Visit 1 6. Those who have initiated or changed immunological treatment within one month prior to Visit 1; 7. Persons who underwent surgery in nasal cavity within 3 months prior to Visit 1 8. Patients with hypertrophic cardiomyopathy, cancer, mental nervous system, kidney, liver, cardiovascular system, respiratory system, endocrine system, central nervous system, etc., who can prevent the completion of this clinical trial or evaluation of safety. 9. Patients with renal failure (Creatine Cleaning Rate <50mL/min), who are undergoing dialysis 10. Persons with drug-absorbing disorder caused by experience in gastrointestinal surgery or gastrointestinal disorders 11. Person with phenylketonuria 12. Do not administer to the patient as below 1) Patients who overreact to the composition and hydroxyzine or piperazine of this drug 2) Patients with renal failure (CLCR: Creatinine Clearance < 10mL/min), patients undergoing hemodialysis 3) Since this drug contains lactose, patients with genetic problems such as galactose intolerance, Lapp Lactase deficiency or glucose-galactose malabsorption. 13. Persons who take or are expected to be inevitable to take the following drugs during the clinical trial period (unless the following drugs have passed the minimum time limit given on the basis of the screening date) - Systematic, intranasal and ophthalmic H1 antihistamine (3 days, 10 days for continuous agents such as Loratadine, fexofenadine, cetirizine, 14 days for ketoifen, 3 months for application of antimine) - Intranasal chromolyn, nedocromil (14 days) - Anticholinergic (7 days, only 3 days for intranasal) - Intranasal and systemic demongestants (3 days) - Systemic corticostroids (30 days), and ophthalmic and phosphatic corticostroids (14 days, except for the 14th, single application Corticostroids, which are administered with a stable dose of Corticosteroids for suction more than 4 weeks prior to screening. - Reserpine (3 days) - Ryukotryen adjuster (7 days, except Montelukast) - Whole body antibiotic (three days, but only seven days for Azithromycin) - NSAIDS (2 days) 14. Patients with an hypersensitivity to investigational products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Daytime Nasal Symptom Score change | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Daytime Nasal Symptom Score change;Mean Nighttime Nasal Symptom Score change;Change of each category in Mean Daytime Nasal Symptom Score(DNSS);Change of each category in Mean Nighttime Nasal Symptom Score(NNSS);Pediatric Rhinoconjunctivitis Quality of Life Questionnaire PRQLQ;Evaluation of the Subject for Overall Treatment Effects;Evaluation of the investigator for Overall Treatment Effects;Evaluation of the primary and secondary end points with/without Asthma | — |
Countries
Korea, Republic of
Contacts
Public ContactYeong Rha
Kyung Hee University Hospital
Outcome results
None listed