None listed
Conditions
Interventions
Drug : [Group 1]
Group A receives 100 PAU at week 1 and 200 PAU at week 2 as the induction phase.
200 PAU is administered for 3 to 16 weeks as a maintenance phase.
Group B (placebo group) is the plac
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged 19 - 65years with allergic rhinitis caused by the American house dust mite antigen. 2) MAST test for American house dust mite antigen = Class 3 3) ImmunoCAP®((Thermofisher, Uppsala, Sweden)) titer > 3.49 kUA/L for the American house dust mite antigen. 4) Determined to be suitable for clinical trials as a result of laboratory tests. 5) After resting for 5 minutes, in a sitting position 90 mmHg = systolic pressure = 139 mmHg and 60 mmHg = diastolic pressure =89 mmHg. 6) Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma). 7) In the case of female patients, those who have agreed to use contraception throughout the clinical trial period 8) A patients who has signed a written consent to participate in this clinical trial voluntarily
Exclusion criteria
Exclusion criteria: 1) Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines. 2) MAST test for Seasonal Allergy antigen = Class 2 3) In case of lactation or pregnancy. 4) If an infectious disease that may affect this study is identified. 5) Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug. 6) Patients taking or taking drugs that may affect epinephrine (adrenaline) such as ß-blockers. 7) Patients taking drugs that may affect efficacy evaluation. 8) In case of taking other investigational drugs or bioequivalence study drugs within 6 months before the first administration of clinical trial drugs. 9) Patients with uncontrolled hypertension. 10) Patients who received biologic agents (eg Anti-IgE) for the treatment of allergic diseases within 6 months prior to the first dose of investigational drug 11) If there is a skin disease or tattoo at the site where the clinical trial drug is applied. 12) If you have an infectious disease such as active tuberculosis. 13) If you have acute or chronic inflammatory disease. 14) Immunosuppressive treatment or systemic steroid treatment. 15) In case of contraindications to adrenaline drugs. 16) If you have received or are taking tranquilizers or psychotropic drugs. 17) Those who show the following values in any of the following ECG items at the time of the screening visit. - PR interval > 210 msec - QRS complex > 120 msec - QTcF > 450 msec 18) Those who cannot use a medically acceptable method of contraception during the entire clinical trial period Medically acceptable contraceptive methods include: - abstinence - Use of an intrauterine device (intrauterine system) with a proven rate of pregnancy failure in the spouse (or partner) - Simultaneous use of barrier contraceptive methods (male or female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges) and spermicide - Surgery by yourself or your partner 19) A person who is judged unsuitable for participation in the study by the study director or person in charge for other reasons. 20) If the allergy skin prick test is negative for the American house dust mite antigen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs;Health examination;laboratory test;Electrocardiography;Adverse Event;Local and systemic adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergic rhinitis symptom improvement rate;American house dust mite specific Ig G4;American house dust mite specific Ig E;Total Nasal Symptom Score (TNSS);Skin Prick Test (SPT) | — |
Countries
Korea, Republic of
Contacts
Public ContactHeejeong Kim
Yonsei University Health System, Severance Hospital
Outcome results
None listed