A Phase 1 interventional study of Allergen extract in Allergic Rhinitis, sponsored by Gachon University Gil Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-03-11.
Sponsored by Gachon University Gil Medical Center · Phase 1, Interventional, and Treatment
The investigators performed open-labeled pilot study which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis.
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 solution from maximal concentration of allergen extract for subcutaneous immunotherapy (30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and 1:1/10 weight/volume for dog hair/dander, HollisterStier, New Orleans, USA) in volume of 0.1ml. After the first dose, allergen concentration was escalated 3-fold at second dose, and 10-fold at third dose if there was no or mild local or systemic hypersensitivity reaction. The allergen concentration did not change at second or third dose if there was moderate local or systemic reaction. The allergen concentration was decreased by 10 or 100-fold from previous concentration if there was severe local or systemic reaction.
The investigators evaluated parameters regarding allergic rhinitis within a week before the first injection and 4 months after the first injection. These parameters included Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20), and Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life. Skin prick test, intradermal test, blood sampling for serum allergen-specific IgE, exhaled nitric oxide, and nasal lavage for Th1, Th2, and Treg cytokines were also included. Adverse events were recorded and graded according to Muller's classification and Ring and Messmer's classification.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 12 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Gachon University Gil Medical Center is the lead sponsor of 88 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Causal allergen such as D. farinae (30 AU/ml), D. pteronyssinus (30 AU/ml), cat hair (10 AU/ml), dog hair/dander (1:1/10 w/v), or combination of those. Allergen extract, HollisterStier, New Orleans, USA. Intralymphatic injection in volume of 0.1 ml, three times with 4-week interval. Concentration was increased, decreased, or unchanged at 2nd or 3rd injection according to local or systemic reaction after previous injection
Biological: Allergen extract
Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those
RQLQ
Rhinoconjunctivitis Quality of Life Questionnaire
Time frame: Baseline and 4 months after the first injection
SNOT-20
Sino-Nasal Outcome Test-20
Time frame: Baseline and 4 months after the first injection
Skin reactivity
Allergen/histamine ratio of mean wheal diameter in skin prick test, and allergen/saline ratio of mean wheal diameter in intradermal test
Time frame: Baseline and 4 months after the first injection
Serum total and allergen-specific IgE and IgG4 level
Serum total and allergen-specific IgE and IgG4 level using UNICAP, Thermofisher Scientific, Sweden
Time frame: Baseline and 4 months after the first injection
Nasal reactivity
Symptom score and volume 2-6 cm in acoustic rhinometry during nasal provocation test with D. farinae and/or D. pteronyssinus in allergic rhinitis patients sensitized to house dust mite
Time frame: Baseline and 4 months after the first injection
Cytokines in nasal lavage fluid
Cytokines of Th1, Th2, and Treg in nasal lavage fluid
Time frame: Baseline and 4 months after the first injection
Exhaled NO
Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
Time frame: Baseline and 4 months after the first injection
Respiratory and dermatologic symptoms provoked by allergen exposure in daily life
Visual analogue scale of respiratory and dermatologic symptoms provoked by allergen exposure in daily life (ranged from 0 to 100)
Time frame: Baseline and 4 months after the first injection
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Gachon University Gil Medical Center