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Intralymphatic immunotherapy with Tyrosine S®, allergen extract for immunotherapy

Not Applicable
Recruiting
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
Inclusion Criteria

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)

Exclusion Criteria

- 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
NameTimeMethod
rhinoconjunctivitis quality of life questionnaire (RQLQ)
Secondary Outcome Measures
NameTimeMethod
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
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