Intralymphatic immunotherapy with Tyrosine S®, allergen extract for immunotherapy
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001777
- Lead Sponsor
- Gachon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Allergic rhinitis to house dust mite (Df, Dp), cat or dog
- More than 3mm reaction at skin prick test for Df, Dp, cat or dog
or more than class 3 at serum specific IgE level (ImmunoCAP® or multiple allergosorbent test)
- Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline
- Forced expiratory volume in 1 second (FEV1) less than 50% of predicted value if there is comorbid asthma.
- Subject rejects the enrollment into study
- Low compliance
- Pregnancy or lactation
- Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
- Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immnosuppressant including systemic glucocorticosteroid within last 2 weeks
- Prior history of allergen-specific immunotherapy
- Allergic rhinitis caused by other perennial or seasonal allergen
- Vulnerable volunteer
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rhinoconjunctivitis quality of life questionnaire (RQLQ)
- Secondary Outcome Measures
Name Time Method Sino-Nasal outcome Test (SNOT-20) ;Allergen wheal diameter in skin prick test and intradermal test ;cut-off point of concentration in nasal provocation test for D. farinae and D. pteronyssinus ;Serum total IgE level;Serum allergen specific IgE and IgG4 level ;Levels of IL-4, IL-5, IL-10, IL-12, IL-13, IFN-g, and TGF-b cytokines in nasal lavage fluid ;Cell count of inflammatory cell in nasal mucosa;Subjects' recognition of causal allergens, their avoidance, and allergen-specific immunotherapy;Subjects' willingness to pay for allergen avoidance, and allergen-specific immunotherapy;Local or systemic adverse reaction during intralymphatic immunotherapy;Expression of CD 63 on cell membrane of peripheral blood basophil during stimulation with causal allergen