Status:
TERMINATED
Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
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
We will perform double-blinded placebo-controlled randomized clinical trial which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Der...
Detailed Description
After informed consent, subjects will be randomly assigned to ILIT group or placebo group in double-blind manner. In both group, causal allergen or placebo will be injected into inguinal lymph node th...
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, immnosuppressant 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 :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02269566
Start Date
August 1 2014
End Date
March 1 2016
Last Update
August 11 2016
Active Locations (1)
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1
Gachon University Gil Medical Center
Incheon, South Korea, 405-760