Status:
COMPLETED
Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis
Lead Sponsor:
Gachon University Gil Medical Center
Collaborating Sponsors:
Thermo Fisher Scientific, Inc
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The investigators performed open-labeled pilot study which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (...
Detailed Description
After informed consent, causal allergen was injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. Initial dose of allergen was 1,000-fold diluted solu...
Eligibility Criteria
Inclusion
- 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 (UNICAP or MAST)
Exclusion
- Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline
- 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, immunosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks
- Prior history of allergen-specific immunotherapy
- Allergic rhinitis caused by other perennial or seasonal allergen
- Vulnerable volunteer
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02301884
Start Date
November 1 2013
End Date
March 1 2015
Last Update
March 11 2015
Active Locations (1)
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1
Gachon University Gil Medical Center
Incheon, South Korea, 405-760